# K092948: Aplio MX Ssa-780A, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 9, 2009 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894632 (1989). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092179: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001, Toshiba America Medical Systems, In.C (2009) Summary page 1.
- K091295: Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0, Toshiba America Medical Systems, In.C (2009) Summary page 1.

## Recalls of this device
- Aug 5, 2013 · Class II · Z-0121-2014: The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mo

## Indications for use
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO MX MODEL SSA-780A is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K092948
Methodology: https://510kreport.com/methodology