# Accutome Ultrasound, Inc.

- Location (FDA's records): Malvern, PA
- FDA decisions: 3 (2004–2009): 3 510(k) clearances
- Product codes: IYO (2), HKX (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 5 (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
- Mentor Ophthalmics, Inc.: 1 (https://510kreport.com/company/mentor-ophthalmics)
- Accutome, Inc.: 1 (https://510kreport.com/company/accutome)

## Firms that cite its devices most
- Accutome, Inc.: 4 (https://510kreport.com/company/accutome)
- Accutome, Inc. Doing Business AS Keeler USA: 1 (https://510kreport.com/company/accutome-doing-business-as-keeler-usa)

## Its most-cited devices
- K070943: B-Scan Plus (2007), cited by 3
- K042752: Accupach V (2004), cited by 2

## Recent decisions
- K083377: Accupen (Jul 27, 2009)
- K070943: B-Scan Plus (Apr 19, 2007)
- K042752: Accupach V (Nov 10, 2004)

Source page: https://510kreport.com/company/accutome-ultrasound