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HS70A Diagnostic Ultrasound System

by Samsung Medison Co., Ltd. 3 variants

510(k) K173713

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173713↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173713 Date8 Mar 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-2275-2019 FDA Class II initiated 25 Jul 2019

    There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The HS70A Diagnostic Ultrasound System is a diagnostic imaging device classified as an ultrasound machine, designed for real-time visualization of internal body structures using high-frequency sound waves. It provides detailed imaging across multiple applications, including abdominal, vascular, obstetrics/gynecology (OB/GYN), musculoskeletal, breast, and small parts examinations, leveraging advanced beamforming technology for enhanced resolution and tissue differentiation.

This system is intended for use in clinical settings such as hospitals, diagnostic centers, and outpatient facilities. Supplied as a reusable medical device, it requires proper sterilization and maintenance protocols as outlined in manufacturer guidelines. The HS70A complies with FDA 510(k) clearance (K173713) and EU MDR authorizations, ensuring adherence to regulatory standards for diagnostic ultrasound equipment. No specific MRI safety classification is indicated in the available data.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical applications is the HS70A Diagnostic Ultrasound System approved for?

    The HS70A is designed for a broad range of diagnostic imaging applications, including abdominal scans, vascular studies, obstetrics/gynecology (OB/GYN) examinations, musculoskeletal assessments, breast imaging, and small parts evaluations. Its advanced beamforming technology enhances resolution and tissue differentiation, making it versatile for these common ultrasound procedures in clinical settings like hospitals and outpatient facilities.

  • Is the HS70A a single-use or reusable device, and what maintenance is required?

    The HS70A is a reusable medical device, meaning it is intended for repeated use across multiple patients. Since it is reusable, it must undergo proper sterilization and maintenance protocols as specified by the manufacturer to ensure safety, functionality, and compliance with regulatory standards. These protocols typically include cleaning, disinfection, and periodic servicing to maintain performance.

  • How is the regulatory status of the HS70A defined in the U.S. and EU markets?

    In the U.S., the HS70A Diagnostic Ultrasound System holds FDA 510(k) clearance under the classification of substantially equivalent (SESE) to a predicate device, with the clearance number K173713. In the EU, it complies with the Medical Device Regulation (MDR), ensuring it meets stringent regulatory requirements for diagnostic ultrasound equipment in that market.

  • What type of advisory committee was involved in the FDA review process for this device?

    The HS70A was reviewed by the FDA’s Radiology (RA) Advisory Committee during its 510(k) clearance process. This committee provides expert input on the safety and effectiveness of radiology-related devices, including ultrasound systems, to help inform regulatory decisions.