SNC350p (TNC) 1045000-1Z

GUDID 05060608880232

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe
Primary Device ID05060608880232
NIH Device Record Keye4be263a-5ddc-411c-81d7-b32855fb57f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSNC350p (TNC)
Version Model Number1045400Z
Catalog Number1045000-1Z
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
Special Storage Condition, SpecifyBetween 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 18.7 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
Special Storage Condition, SpecifyBetween 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]
GS105060608880232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [SNC350p (TNC)]

B01610450001Z0Radiation therapy QA device.
05060608880232Radiation therapy QA device.

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