# K022400: Ssa-700A, Aplio Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Aug 6, 2002 after 14 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: 5 generations back to K894632 (1989). 23 ancestors in all.
210 later devices descend from it; 1 cites 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)
- K992886: Powerview Ultrasound Workstation, Uidm-400A, Toshiba America Medical Systems, In.C (1999) Summary page 1.
- K013633: Ssa-770A, Aplio Ultrasound System, Toshiba America Medical Systems, In.C (2001)

## Most influential descendants
- 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
- K080160: Aplio Artida, Model SSH-880CV Diagnostic Ultrasound System (2008), 181 descendants of its own

## Recalls of this device
- Feb 2, 2007 · Not classified · Z-0986-2007: When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement dis

## 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/K022400
Methodology: https://510kreport.com/methodology