# K182894: HM70A Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Jan 22, 2019 after 99 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: 27 generations back to K924432 (1993). 330 ancestors in all.
10 later devices descend from it; 1 cites it directly.
6 of 341 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153408: HM70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 5.
- K142466: UGEO PT60A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2014) Summary page 25.
- K170493: HS50 / HS60 Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 24.
- K140254: EZONO 4000, Ezono AG (2014) Summary page 27.

## Most influential descendants
- K191055: HS40 Diagnostic Ultrasound System (2019), 9 descendants of its own
- K200339: HS40 Diagnostic Ultrasound System (2020), 8 descendants of its own
- K210713: HM70 EVO Diagnostic Ultrasound System (2021), 4 descendants of its own
- K220269: HM70 EVO Diagnostic Ultrasound System (2022), 3 descendants of its own
- K233112: HM70 EVO Diagnostic Ultrasound System (2023), 2 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/K182894
Methodology: https://510kreport.com/methodology