# K103645: Aplio XG Diagnostic Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Toshiba Medical Systems Corporation, Japan
- Decided: Jan 12, 2011 after 30 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
90 later devices descend from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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

Source page: https://510kreport.com/device/K103645
Methodology: https://510kreport.com/methodology