Qumulate

GUDID 00856100006202

VARIAN MEDICAL SYSTEMS, INC.

Accelerator system quality assurance device
Primary Device ID00856100006202
NIH Device Record Key977af9b4-1899-4e71-866d-a9cde9121308
Commercial Distribution StatusIn Commercial Distribution
Brand NameQumulate
Version Model Number3.1
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
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 Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856100006202 [Primary]

FDA Product Code

OUGMedical device data system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-10

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

00855141006349 - Eclipse Treatment Planning System2024-12-30
00856100006370 - ARIA Radiation Therapy Management2024-12-30
10856100006223 - Gating Reflector Block2024-12-11
00850800006074 - Vitesee2024-11-11
00858086006467 - Varian Collimator Accessories 30 CM wedge set lower (JITKIT)2024-10-07
00858086006474 - Varian Collimator Accessories 30 CM wedge set upper (JITKIT)2024-10-07
00858086006481 - Varian Collimator Accessories 20 cm wedge set lower2024-10-07
00858086006498 - Varian Collimator Accessories Lead wedge set lower (JITKIT)2024-10-07

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.