Diagnostic Ultrasound Transducer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K953759 ↗

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?

  It is used to emit and receive ultrasonic waves to generate diagnostic images of internal body structures as a component of an ultrasound system in clinical radiology settings.

• Is the transducer sterile or single-use?

  The device is supplied as non-sterile and is designed for reuse; it is not intended for single-use applications and requires proper cleaning and disinfection between uses per facility protocols.

• How is the transducer supplied and what is needed to operate it?

  It is supplied as a reusable component that must be connected to an ultrasound console to function; it does not operate independently and requires integration with a compatible ultrasound system.

• What regulatory clearance does this transducer have?

  It received traditional 510(k) clearance from the FDA under submission K953759 and is classified under product code ITX, indicating substantial equivalence to a legally marketed predicate device.