4000 Au Ultrasound Imaging System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K944485 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-A

  Class II

  FDA 510(k) K953530 Active Cleared 8 Apr 1996

• The Galileo Line -- Planet 100, 200 & 300 & Star

  Class II

  FDA 510(k) K923860 Active Cleared 4 Feb 1993

• Artoscan

  Class II

  FDA 510(k) K931022 Active Cleared 7 Oct 1993

• Topographic Brain Mapping Option

  Class II

  FDA 510(k) K934050 Active Cleared 3 Feb 1994

• Genesis II

  Class II

  FDA 510(k) K871697 Active Cleared 6 Nov 1987

• Galileo Evoked Potentialre

  Class II

  FDA 510(k) K963662 Active Cleared 26 Feb 1997

See all devices from Biosound, Inc. →