The following data is part of a premarket notification filed by Carl Zeiss Meditec Ag with the FDA for Convivo In Vivo Pathology Suite.
| Device ID | K211156 |
| 510k Number | K211156 |
| Device Name: | CONVIVO In Vivo Pathology Suite |
| Classification | System, Image Processing, Radiological |
| Applicant | Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 Jena, DE D-07445 |
| Contact | Juergen Berger |
| Correspondent | Maria Golovina Carl Zeiss Meditec Inc 5300 Central Parkway Dublin, CA 94568 |
| Product Code | LLZ |
| Subsequent Product Code | GWG |
| Subsequent Product Code | OWN |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-04-19 |
| Decision Date | 2021-12-29 |