# K110870: Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 4, 2011 after 189 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: 13 generations back to K935595 (1995). 129 ancestors in all.
89 later devices descend from it; 2 cite it directly.
0 of 219 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103645: Aplio XG Diagnostic Ultrasound System, Toshiba Medical Systems Corporation, Japan (2011) Summary page 1.
- K090158: Aplio Artida V2.0 SSH-880CV, Toshiba America Medical Systems, In.C (2009) Summary page 1.
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4, GE Healthcare (2009) Summary page 1.

## Most influential descendants
- 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
- K133761: Aplio 500/400/300 Diagnostic Ultrasound System V4.0 (2014), 72 descendants of its own
- K142517: SoftVue (2014), 49 descendants of its own
- K150949: FibroScan (2015), 42 descendants of its own

## Indications for use
The Aplio TUS-A500/A400/A300 (v2.0) Diagnostic Ultrasound System is indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, transesophageal, and musculo-skeletal (both conventional and superficial).

Source page: https://510kreport.com/device/K110870
Methodology: https://510kreport.com/methodology