7.5 MHz Short Focus Fluid Offset Probe #041-726T

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

510(k) Number

K860494 ↗

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

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  FDA 510(k) K863710 Active Cleared 14 Oct 1986

• Ausonics Opus 2 Realtime Ultrasound Scanner

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  FDA 510(k) K933916 Active Cleared 3 Oct 1994

• Ausonics Opus 1 System, Annular Array Option

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  FDA 510(k) K920307 Active Cleared 19 May 1992

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

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  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. →

• What is the 7.5 MHz Short Focus Fluid Offset Probe #041-726T used for?

  The 7.5 MHz Short Focus Fluid Offset Probe #041-726T is a medical imaging device designed for ultrasound examinations. It operates at a frequency of 7.5 MHz and features a short focus with a fluid offset design for optimal imaging performance.

• Is the 7.5 MHz Short Focus Fluid Offset Probe reusable or single-use?

  The 7.5 MHz Short Focus Fluid Offset Probe #041-726T is supplied as a single-use device. It should not be reused and should be stored according to the manufacturer's instructions to maintain its imaging performance.

• What regulatory approvals does the 7.5 MHz Short Focus Fluid Offset Probe have?

  The 7.5 MHz Short Focus Fluid Offset Probe #041-726T has received FDA 510(k) clearance with the product code ITX. It is not MRI compatible and should be used according to its intended purpose for ultrasound examinations.

• Who manufactures the 7.5 MHz Short Focus Fluid Offset Probe #041-726T?

  The 7.5 MHz Short Focus Fluid Offset Probe #041-726T is manufactured by Ausonics Pty, Ltd. The company is located at 40 Crane Hill Rd., Suffield, CT 06078, and the contact person is WILLIAM C NEALON.