# Imvaria, Inc.

- Location (FDA's records): Berkeley, CA
- FDA decisions: 3 (2024–2025): 2 510(k) clearances and 1 De Novo grant
- Product codes: QWO (3)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Imbio, LLC: 1 (https://510kreport.com/company/imbio)

## Its most-cited devices
- DEN220040: Fibresolve (2024), cited by 3

## Recent decisions
- K252041: Fibresolve (with PCCP) (Nov 7, 2025)
- K241891: ScreenDx (Jan 10, 2025)
- DEN220040: Fibresolve (Jan 12, 2024)

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