# Exo Imaging

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 4 (2021–2026): 4 510(k) clearances
- Names in FDA's records: Exo Imaging (2); Exo Imaging, Inc. (2)
- Product codes: QIH (2), IYN (2)
- 510(k) review time since 2016: median 103 days, against 118 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (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 whose devices it cites most
- Dia Imaging Analysis, Ltd.: 1 (https://510kreport.com/company/dia-imaging-analysis)
- Butterfly Network, Inc.: 1 (https://510kreport.com/company/butterfly-network)

## Its most-cited devices
- K240953: AI Platform 2.0 (AIP002) (2024), cited by 1
- K211527: Exo Iris (2021), cited by 1

## Recent decisions
- K260217: AI Platform 2.2 (AIP002) (Feb 24, 2026)
- K240953: AI Platform 2.0 (AIP002) (Aug 5, 2024)
- K222198: Exo Iris  (El2001) (Nov 9, 2022)
- K211527: Exo Iris (Aug 20, 2021)

Source page: https://510kreport.com/company/exo-imaging