K211156 is an FDA 510(k) clearance for the CONVIVO In Vivo Pathology Suite. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on December 29, 2021, 254 days after receiving the submission on April 19, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K211156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2021 |
| Decision Date | December 29, 2021 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |