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HM70 EVO Diagnostic Ultrasound System

by Samsung Medison Co., Ltd. 2 variants

510(k) K210713

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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210713↗

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 NumberK210713 Date9 Jul 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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 HM70 EVO Diagnostic Ultrasound System is a diagnostic imaging device classified as an ultrasound imaging system (Nomenclature Code: IYN). It generates real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes. The system supports a range of applications, including obstetrics, cardiology, abdominal, and vascular imaging, with advanced transducer options for enhanced visualization.

This system is supplied as a reusable medical device, intended for use in clinical, hospital, or diagnostic imaging settings. It is not sterile and requires proper cleaning and maintenance between uses. The device adheres to FDA 510(k) clearance (K210713) and MDR compliance, ensuring adherence to regulatory standards for diagnostic ultrasound equipment. Storage and operation follow manufacturer guidelines to maintain performance and safety, with no specific MRI safety restrictions noted.

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