FDA.report

Roentgen Works

Primary DI
00850631008858
Brand
Roentgen Works
Company
Brit Systems, LLC
Model
7.2.0
Device description
Roentgen Works 7.2.0 is a PACS, RIS, and Viewer.
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LLZSystem, Image Processing, Radiological
LMBDevice, Digital Image Storage, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
LMBDevice, Digital Image Storage, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850631008858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850631008858008506310088588506310088580850631008858

GMDN Terms

TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Contacts

PhoneEmail
214-630-0636sales@brit.com

Regulatory Flags

DUNS number
941442410
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850631008827Roentgen Works7.1.02026-03-05
00850631008810Roentgen Works7.0.22026-01-01
00850631008803Roentgen Works7.0.12025-12-11
00850631008773Pacs View2.4.3.02025-11-20
00850631008780BRIT Lite3.4.32025-11-20
00850631008797Roentgen Works7.0.02025-11-20
00850631008759Roentgen Works6.6.22025-08-14
00850631008742Roentgen Works6.6.12025-08-07
00850631008735Roentgen Works6.6.02025-07-31
00850631008728Roentgen Works6.5.02025-05-31
00850631008711Roentgen Works6.4.12025-03-28
00850631008704Roentgen Works6.4.02025-03-10
00850631008698Roentgen Works6.3.22024-12-06
00850631008681Roentgen Works6.3.12024-11-22
00850631008674Roentgen Works6.3.02024-11-19
00850631008667Roentgen Works6.2.12024-10-29
00850631008650Roentgen Works6.2.02024-10-08
00850631008643Roentgen Works6.1.12024-08-01
00850631008636Roentgen Works6.1.02024-07-26
00850631008629Roentgen Works6.0.12024-07-12

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17540262090154Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-03-09
06971576834334uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
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08800169200134ON3D3D ONS, INC.LLZ2026-02-19
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00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00860015443526CARPLCarpl.AI, Inc.LLZ2026-02-16