# Mvision AI OY

- Location (FDA's records): Helsinki, FI
- FDA decisions: 3 (2022–2025): 3 510(k) clearances
- Names in FDA's records: Mvision AI OY (2); MVision AI (1)
- Product codes: QKB (2), MUJ (1)
- 510(k) review time since 2016: median 232 days, against 173 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Mirada Medical, Ltd.: 1 (https://510kreport.com/company/mirada-medical)
- Oncospace, Inc.: 1 (https://510kreport.com/company/oncospace)

## Its most-cited devices
- K212915: MVision AI Segmentation (2022), cited by 1

## Recent decisions
- K250064: Dose+ (1.0) (Sep 4, 2025)
- K241490: Contour+ (MVision AI Segmentation) (Oct 18, 2024)
- K212915: MVision AI Segmentation (May 3, 2022)

Source page: https://510kreport.com/company/mvision-ai