The following data is part of a premarket notification filed by Televere Systems with the FDA for Visix Imaging.
| Device ID | K082623 |
| 510k Number | K082623 |
| Device Name: | VISIX IMAGING |
| Classification | System, Image Processing, Radiological |
| Applicant | TELEVERE SYSTEMS 471 STAGE RD. Charlton, NY 12019 |
| Contact | Barbara Deay |
| Correspondent | Barbara Deay TELEVERE SYSTEMS 471 STAGE RD. Charlton, NY 12019 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2009-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851800007092 | K082623 | 000 |
| 00851800007054 | K082623 | 000 |
| 00851800007047 | K082623 | 000 |
| 00851800007030 | K082623 | 000 |