Medical Device Manufacturer · US , Malvern , PA

Accutome Ultrasound, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2004

Recent clearances: ACCUPEN, B-SCAN PLUS, ACCUPACH V

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Accutome Ultrasound, Inc. Radiology ✕

2 devices

1-2 of 2

Cleared Apr 19, 2007

Radiology · 15d

Cleared Nov 10, 2004

Radiology · 37d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 25, 2026