# K032281: Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Aug 6, 2003 after 13 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894632 (1989). 37 ancestors in all.
209 later devices descend from it; 2 cite it directly.
0 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013633: Ssa-770A, Aplio Ultrasound System, Toshiba America Medical Systems, In.C (2001) Summary page 1.
- K022400: Ssa-700A, Aplio Diagnostic Ultrasound System, Toshiba America Medical Systems, In.C (2002)
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 1.
- K991842: System Five/Echopac with Strain Rate Imaging, Ge Vingmed Ultrasound (1999) Summary page 1.

## Most influential descendants
- K063130: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 (2006), 205 descendants of its own
- K072000: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 (2007), 203 descendants of its own
- K072826: Aplio Artida Diagnostic Ultrasound System (2007), 182 descendants of its own
- K080160: Aplio Artida, Model SSH-880CV Diagnostic Ultrasound System (2008), 181 descendants of its own
- K081065: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 (2008), 118 descendants of its own

## Indications for use
The APLIO 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, musculo-skeletal (both conventional and superficial) and laparoscopic.

Source page: https://510kreport.com/device/K032281
Methodology: https://510kreport.com/methodology