# K150478: A35 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Mar 26, 2015 after 30 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: 20 generations back to K924432 (1993). 194 ancestors in all.
97 later devices descend from it; 4 cite it directly.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112339: Accuvix A30 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2011) Summary page 4.
- K143089: WS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 17.
- K143264: H60 V2.00 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 27.
- K142466: UGEO PT60A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 24.
- K133505: Sonoace R7 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 28.

## Most influential descendants
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own
- K152962: HS70A Diagnostic Ultrasound System (2015), 90 descendants of its own
- K153529: WS80A Diagnostic Ultrasound System (2016), 89 descendants of its own
- K153408: HM70A Diagnostic Ultrasound System (2015), 65 descendants of its own
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own

## Indications for use
The A35 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel

Source page: https://510kreport.com/device/K150478
Methodology: https://510kreport.com/methodology