# K121422: Aplio 500/400/300 Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Toshiba Medical Systems Coporation, Japan
- Decided: Aug 16, 2012 after 94 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: 14 generations back to K935595 (1995). 130 ancestors in all.
85 later devices descend from it; 3 cite it directly.
0 of 216 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110870: Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System; Aplio Diagnostic Ultrasound System, Toshiba America Medical Systems, In.C (2011) Summary page 1.

## Most influential descendants
- 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
- K160524: FibroScan 530 Compact (2016), 41 descendants of its own

## Indications for use
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO 500 MODEL TUS-A500, APLIO 400 MODEL TUS-A400 and APLIO 300 MODEL TUS-A300 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, intra-operative (abdominal), pediatric; small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, and musculoskeletal (both conventional and superficial),

Source page: https://510kreport.com/device/K121422
Methodology: https://510kreport.com/methodology