Adaptor Plate for GMF 1122AZ

GUDID B0161122AZ0

Accessory to the 1177 MapCHECK2.

SUN NUCLEAR CORP.

Accelerator system quality assurance device Accelerator system quality assurance device
Primary Device IDB0161122AZ0
NIH Device Record Key7d701cd5-05ce-48c4-9e9f-a7a4fbf20413
Commercial Distribution Discontinuation2019-06-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAdaptor Plate for GMF
Version Model Number1122AZ
Catalog Number1122AZ
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 *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 *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.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0161122AZ0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-14
Device Publish Date2017-01-14

Devices Manufactured by SUN NUCLEAR CORP.

05060608881178 - Precision Cut EBT3 GafChromic™ Film2024-01-10 Precision Cut EBT3 GafChromic™ Film
05060608881123 - SunSCAN 3D2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
05060608881130 - SunSCAN 3D2023-06-16 The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commis
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.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.