# K153408: HM70A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Dec 21, 2015 after 26 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: 22 generations back to K924432 (1993). 201 ancestors in all.
65 later devices descend from it; 3 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130803: Ugeo H70C Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2013) Summary page 5.
- K151663: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 18.
- K101455: Eko 7 Diagnostic Ultrasound System, Medison Co., Ltd. (2010) Summary page 24.
- K103397: Accuvix XG Diagnostic Ultrasound System, Medison Co., Ltd. (2011) Summary page 24.

## Most influential descendants
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own
- K171070: WS80A Diagnostic Ultrasound System (2017), 42 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own

## Indications for use
The HM70A 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, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.

Source page: https://510kreport.com/device/K153408
Methodology: https://510kreport.com/methodology