Doppler Upgrade for Ausonics Opus 1 Real Time Scan

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K905488 ↗

FDA Product Code

LMB

FDA applicant

Ausonics Pty , Ltd.

Device Class

Class I

Regulation

21 CFR Part 892.2010

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Alpha S/D Diagnostic X-Ray Mammography Unit

  Class II

  FDA 510(k) K863710 Active Cleared 14 Oct 1986

• Ausonics Opus 2 Realtime Ultrasound Scanner

  Class II

  FDA 510(k) K933916 Active Cleared 3 Oct 1994

• Ausonics Opus 1 System, Annular Array Option

  Class II

  FDA 510(k) K920307 Active Cleared 19 May 1992

• 3.5. Mhz Probe for Ausonics 150 & 357 Real Time Ca

  Class II

  FDA 510(k) K851616 Active Cleared 29 Jul 1985

• Ausonics 5000

  Class II

  FDA 510(k) K896714 Active Cleared 11 Jun 1990

• U.I. Octoson

  Class II

  FDA 510(k) K801675 Active Cleared 23 Oct 1980

See all devices from Ausonics Pty, Ltd. →