Medical Device Manufacturer · US , N. Yonkers , NY

Ultrasonix, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1985

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ultrasonix, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Sep 30, 1987

MODIFIED RADIUS - MODEL NUMBER MM 5000

Cardiovascular · 155d

Cleared Oct 23, 1985

750 SD ULTRASOUND SCANNER(MODIFICATION)

Cardiovascular · 176d

Data Source

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

Last updated: Apr 28, 2026