# K211156: CONVIVO In Vivo Pathology Suite

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Dec 29, 2021 after 254 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002788 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181116: Convivo, Carl Zeiss Meditec, AG (2018) Summary page 4.

## Indications for use
The CONVIVO In Vivo Pathology Suite is a system that contains a surgical endo-microscope and a cloud software module. The Suite allows for real-time, remote collaboration between various clinical teams (i.e., neurosurgical and pathology). The device is not intended for diagnostic purposes or to replace standard practices for tumor margin analysis and frozen sections procedures as part of intra-operative consultation. CONVIVO Surgical Workplace is a surgical endo-microscope that acquires data and creates in-vivo images and image sequences of tissue microstructure. CONVIVO’s fiber optic scanner probe is placed in direct contact with tissue during cranial procedures to create in-vivo confocal laser scanning images of the internal microstructure of tissues. CONVIVO Pathology Workplace (cloud software module) can categorize, archive, and store images created by the acquisition device (such as CONVIVO Surgical Workplace).

Source page: https://510kreport.com/device/K211156
Methodology: https://510kreport.com/methodology