# K013633: Ssa-770A, Aplio Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Nov 13, 2001 after 8 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: 4 generations back to K894632 (1989). 22 ancestors in all.
211 later devices descend from it; 2 cite it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991858: Ssa-390A/Power Vision 8000, Toshiba America Medical Systems, In.C (1999) Summary page 1.
- K992886: Powerview Ultrasound Workstation, Uidm-400A, Toshiba America Medical Systems, In.C (1999) Summary page 1.

## Most influential descendants
- 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
- 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

## 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/K013633
Methodology: https://510kreport.com/methodology