The following data is part of a premarket notification filed by Brit Systems, Inc. with the FDA for Imaging Workbench.
| Device ID | K943383 |
| 510k Number | K943383 |
| Device Name: | IMAGING WORKBENCH |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | BRIT SYSTEMS, INC. 1909 HI-LINE DR., SUITE A Dallas, TX 75207 |
| Contact | Kim Herman |
| Correspondent | Kim Herman BRIT SYSTEMS, INC. 1909 HI-LINE DR., SUITE A Dallas, TX 75207 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1994-11-22 |