# K941593: Diagnostic Ultrasonic Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: May 17, 1996 after 777 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 K894632 (1989). 1 ancestor in all.
404 later devices descend from it; 1 cites it directly.
3 of 406 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894632: Model SSH-140A Ultrasound Imaging System, Toshiba America Medical Systems, In.C (1989) Summary page 1.
- (no number) P3-2 Transcranial Doppler transducer: named in the summary without a submission number

## Most influential descendants
- K970047: Phased Array Transducer - - PSK-20CT (1997), 403 descendants of its own
- K991858: Ssa-390A/Power Vision 8000 (1999), 212 descendants of its own
- K013633: Ssa-770A, Aplio Ultrasound System (2001), 211 descendants of its own
- K022400: Ssa-700A, Aplio Diagnostic Ultrasound System (2002), 210 descendants of its own
- K032281: Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System (2003), 209 descendants of its own

## Indications for use
The PSH-25GT and P3-2 probes are intended for transcranial doppler applications.

Source page: https://510kreport.com/device/K941593
Methodology: https://510kreport.com/methodology