# Medivis, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 3 (2019–2025): 3 510(k) clearances
- Product codes: HAW (1), LLZ (1), OLO (1)
- 510(k) review time since 2016: median 248 days, against 107 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Vital Images, Inc.: 1 (https://510kreport.com/company/vital-images)
- Augmedics, Ltd.: 1 (https://510kreport.com/company/augmedics)

## Firms that cite its devices most
- Medapp S.A.: 1 (https://510kreport.com/company/medapp)
- Immersivetouch: 1 (https://510kreport.com/company/immersivetouch)
- Apoqlar GmbH: 1 (https://510kreport.com/company/apoqlar)

## Its most-cited devices
- K190764: SurgicalAR (2019), cited by 3

## Recent decisions
- K231897: NeuroAlign software (Oct 21, 2025)
- K233725: Spine Navigation System (Jul 26, 2024)
- K190764: SurgicalAR (May 13, 2019)

Source page: https://510kreport.com/company/medivis