TomoDose 1176000-0Z

GUDID 05060608880263

Radiotherapy quality assurance device

SUN NUCLEAR CORP.

Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device
Primary Device ID05060608880263
NIH Device Record Keyeb218595-8907-4497-90dc-a0e174279a4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTomoDose
Version Model Number1176300Z
Catalog Number1176000-0Z
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
Storage Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
Special Storage Condition, SpecifyBetween 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]
GS105060608880263 [Primary]

FDA Product Code

LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic

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

Devices Manufactured by SUN NUCLEAR CORP.

05060608880041 - rf-IVD 22020-08-03 Radiation therapy QA device.
05060608880874 - PlanIQ2020-08-03 Radiation therapy QA software.
05060608880102 - StereoPHAN2020-07-31 Radiation therapy, machine QA device
05060608880751 - IC PROFILER2020-07-31 Radiation therapy QA device.
05060608880768 - IC PROFILER-MR2020-07-31 Radiation therapy QA device.
05060608880959 - Daily QA-MR2020-07-31 Radiation therapy QA device.
05060608880188 - SRS MapCHECK2020-07-30 Radiation therapy QA device.
05060608880232 - SNC350p (TNC)2020-07-30 Radiation therapy QA device.

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.