# Accutome, Inc. Doing Business AS Keeler USA

- Location (FDA's records): Malvern, PA
- FDA decisions: 1 (2025–2025): 1 510(k) clearance
- Product codes: IYO (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (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
- Accutome Ultrasound, Inc.: 1 (https://510kreport.com/company/accutome-ultrasound)

## Recent decisions
- K243227: B-Scan (Jul 11, 2025)

Source page: https://510kreport.com/company/accutome-doing-business-as-keeler-usa