Daily QA-MR 1093000-0MRZ

GUDID 05060608880959

Radiation therapy QA 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 ID05060608880959
NIH Device Record Keyed99fab0-c2f7-47ac-9898-3e1ec1f3c8d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDaily QA-MR
Version Model Number1096300Z
Catalog Number1093000-0MRZ
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
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 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room
Special Storage Condition, SpecifyBetween 0 and 0 *To assure optimum measurement stability, the QA device should stay connected to power at all times and stored in a location that is not exposed to primary beam during clinical treatment
Special Storage Condition, SpecifyBetween 0 and 0 *Store the device in the treatment room, but not in a location where a primary beam may occur
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 at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *To minimize damage to electronics, do not store the device in the treatment room

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [Primary]
GS105060608880959 [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 Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by SUN NUCLEAR CORP.

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-MR2020-07-31Radiation 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.
05060608880249 - SNC600c (TNC)2020-07-30 Radiation therapy QA device.
05060608880263 - TomoDose2020-07-30 Radiotherapy quality assurance device

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