Diagnostic Ultrasound Tranducer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K953819 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

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. →

• What is the Diagnostic Ultrasound Transducer used for?

  The Diagnostic Ultrasound Transducer is a medical device used for diagnostic ultrasound imaging. It converts electrical energy into ultrasound waves and receives reflected echoes to create images of internal body structures in radiology settings.

• How is the Diagnostic Ultrasound Transducer supplied?

  The device is supplied by Biosound, Inc. and is available in various models as indicated by the K953819 authorization number. It is designed specifically for use in radiology settings.

• What is the regulatory status of this device?

  The Diagnostic Ultrasound Transducer is authorized under FDA 510K clearance with product code ITX. It received traditional clearance with a decision code of SESE (Substantially Equivalent) on 1996-03-01.

• Is the Diagnostic Ultrasound Transducer single-use or reusable?

  The device data does not specify whether the Diagnostic Ultrasound Transducer is single-use or reusable. This information would be detailed in the product's specific instructions for use provided by the manufacturer.