# K081065: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Jun 6, 2008 after 52 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: 9 generations back to K894632 (1989). 53 ancestors in all.
118 later devices descend from it; 2 cite it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072000: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0, Toshiba America Medical Systems, In.C (2007) Summary page 1.
- K061682: GE Voluson E8 Ultrasound System, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K082119: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 (2008), 116 descendants of its own
- K090158: Aplio Artida V2.0 SSH-880CV (2009), 98 descendants of its own
- K110870: Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System (2011), 89 descendants of its own
- K121422: Aplio 500/400/300 Diagnostic Ultrasound System (2012), 85 descendants of its own
- K123992: Aplio 500/400/300 V3.0 (2013), 82 descendants of its own

## Indications for use
The Aplio XG 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/K081065
Methodology: https://510kreport.com/methodology