Data / Medical devices / United States / Brit Systems
Brit Systems: FDA-registered device maker in Wallingford, CT, United States, 1 510(k) clearance
Brit Systems is registered with the FDA (registration 1647172) in Wallingford, CT, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 23, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1647172
- FEI number
- 1000306093
- Address
- 135 N Plains Industrial Rd, Wallingford, CT, United States, 06492
- Owner or operator
- BRIT SYSTEMS, LLC (9010913)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 13, 1994
- Registered through
- 2026
- Brand names listed
- BRIT PACS System, IMAGING WORKBENCH, PacsView, Roentgen Files, RIS, Works, Vision
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 23, 2009 | K081168 | BRIT PACS SYSTEMS | LLZ | Substantially Equivalent | Brit Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Digital Image Storage, Radiological
- All makers of System, Digital Image Communications, Radiological
- All makers of System, Image Processing, Radiological
Updated March 23, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.