Ausonics Opus 1 System, Annular Array Option

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K920307 ↗

FDA Product Code

ITX

FDA applicant

Ausonics Pty , Ltd.

Device Class

Class II

Regulation

21 CFR Part 892.1570

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

• 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

• 7.5 Mhz Bi Plane Rectal Probe (P/N: 041-815)

  Class II

  FDA 510(k) K902728 Active Cleared 13 Feb 1991

See all devices from Ausonics Pty, Ltd. →

• What types of ultrasound examinations is the Ausonics Opus 1 System, Annular Array Option specifically designed to improve?

  The Ausonics Opus 1 System with the Annular Array Option is designed to enhance image resolution and detail in ultrasound examinations, which helps radiologists perform more precise diagnostic assessments. The annular array technology is particularly useful for improving clarity in imaging where fine structural details are critical, such as in abdominal, cardiac, or vascular studies.

• Is the Ausonics Opus 1 System, Annular Array Option intended for single-use or reusable applications?

  The device is supplied as a reusable medical instrument. While it is not explicitly labeled as sterile, it must be cleaned and maintained according to standard medical device cleaning protocols to ensure safe reuse in radiology settings.

• How was the regulatory pathway for the Ausonics Opus 1 System, Annular Array Option determined?

  The device was cleared under the FDA’s 510(k) pathway, specifically as substantially equivalent to a predicate device, and was reviewed by the Radiology Advisory Committee. The clearance type is traditional, meaning it followed the standard review process for demonstrating equivalence to an existing approved device.

• What is the primary purpose of the annular array technology in this ultrasound system?

  The annular array technology in the Opus 1 System is engineered to improve image resolution and detail, allowing radiologists to obtain clearer and more precise diagnostic images. This is particularly beneficial for identifying fine anatomical structures or abnormalities during ultrasound examinations.