The following data is part of a premarket notification filed by Brit Systems, Inc. with the FDA for Brit Pacs Systems.
| Device ID | K081168 |
| 510k Number | K081168 |
| Device Name: | BRIT PACS SYSTEMS |
| Classification | System, Image Processing, Radiological |
| Applicant | BRIT SYSTEMS, INC. 1909 HI-LINE DR., SUITE A Dallas, TX 75207 |
| Contact | Robert Murry |
| Correspondent | Robert Murry BRIT SYSTEMS, INC. 1909 HI-LINE DR., SUITE A Dallas, TX 75207 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-24 |
| Decision Date | 2009-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850631008070 | K081168 | 000 |
| 00850631008100 | K081168 | 000 |
| 00850631008094 | K081168 | 000 |
| 00850631008056 | K081168 | 000 |
| 00850631008049 | K081168 | 000 |
| 00850631008360 | K081168 | 000 |
| 00850631008353 | K081168 | 000 |
| 00850631008490 | K081168 | 000 |