# K953530: Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-a

- Pathway: 510(k) (Traditional)
- Applicant: Biosound, Inc.
- Decided: Apr 8, 1996 after 256 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896356 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896356: AU530 Diagnostic Ultrasonic Pulsed Echo System, Esaote Biomedica Spa (1990) Summary page 2.
- K944485: 4000 AU Ultrasound Imaging System, Biosound, Inc. (1995) Summary page 2.
- K902515: Acuson S228 Transducer for Transcranial Color Dopp, Acuson Corp. (1992) Summary page 2.

## Cited in the summary but kept off the family tree
- K836356: Esaote P10 Diagnostic Ultrasound Transducer. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial

Source page: https://510kreport.com/device/K953530
Methodology: https://510kreport.com/methodology