U.I. Octoson

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K801675 ↗

FDA Product Code

LEJ

FDA applicant

Ausonics Pty , Ltd.

Device Class

Class II

Regulation

21 CFR Part 878.4635

Advisory Committee

General, Plastic Surgery

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

• 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 dental imaging does the U.I. OCTOSON provide, and how does it differ from traditional X-ray methods?

  The U.I. OCTOSON is a panoramic dental X-ray device that creates high-resolution, grayscale cross-sectional images of the maxillofacial region, including the jaw and surrounding structures. Unlike traditional intraoral X-rays, which capture limited views of individual teeth, this device uses a scanning mechanism to produce comprehensive panoramic images. This allows clinicians to assess bone structure, tooth alignment, and potential pathologies in a single scan, improving diagnostic accuracy for dental and oral surgery evaluations.

• Is the U.I. OCTOSON designed for single-use or repeated use in clinical settings, and what maintenance is required?

  The U.I. OCTOSON is supplied as a reusable medical instrument for use in dental clinics and oral surgery settings. Since it is a reusable device, it requires proper calibration and maintenance to ensure imaging accuracy and compliance with radiation safety standards. Regular servicing, as recommended by the manufacturer, is essential to sustain performance and reliability over time.

• How was the U.I. OCTOSON evaluated for regulatory approval, and what classification does it hold?

  The U.I. OCTOSON was cleared through the FDA’s Traditional 510(k) pathway and is classified as a Class 2 Radiology device under FDA regulations. The submission was reviewed by the Surgical and Urological Devices (SU) Advisory Committee and determined to be substantially equivalent to a predicate device. This classification reflects its role as a specialized imaging tool requiring compliance with radiation safety standards.

• What kind of clinical environments is the U.I. OCTOSON intended for, and what are its primary diagnostic applications?

  The U.I. OCTOSON is designed for dental clinics and oral surgery settings, where detailed imaging of the maxillofacial region is critical. Its primary diagnostic applications include assessing jawbone structure, tooth positioning, and potential pathologies such as impacted teeth, fractures, or developmental abnormalities. The panoramic cross-sectional imaging helps clinicians plan treatments like extractions, orthodontics, or surgical interventions with greater precision.