Roentgen Files

GUDID 00850631008506

Roentgen Files 4.1.1

Brit Systems, LLC

Radiology PACS software
Primary Device ID00850631008506
NIH Device Record Keye12e2cc2-3f8f-4d1c-b085-95195f5c438e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRoentgen Files
Version Model Number4.1.1
Company DUNS941442410
Company NameBrit Systems, LLC
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 Datefalse
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
GS100850631008506 [Primary]

FDA Product Code

LMBDevice, Digital Image Storage, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-23

On-Brand Devices [Roentgen Files]

00850631008087Roentgen Files 4.1.0
00850631008506Roentgen Files 4.1.1

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