# K894632: Model SSH-140A Ultrasound Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 19, 1989 after 87 days
- Product code: DXK (Echocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
405 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K941593: Diagnostic Ultrasonic Transducer (1996), 404 descendants of its own
- 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

Source page: https://510kreport.com/device/K894632
Methodology: https://510kreport.com/methodology