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HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

by Samsung Medison Co., Ltd. 2 variants

510(k) K230084

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) K230084↗

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 NumberK230084 Date21 Apr 2023ClearedStatusActive
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  • Withdrawn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
Models / Variants
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 HERA W10 and HERA W9 are diagnostic ultrasound systems designed for high-resolution imaging of internal body structures. Classified as diagnostic ultrasound devices, they provide real-time visualization for clinical assessments, including obstetrics, gynecology, abdominal, and cardiac evaluations, as well as fluid analysis.

These systems are intended for use in clinical settings by trained professionals, supplied sterile or non-sterile as specified by the facility. Both models are reusable and comply with FDA 510(k) clearance and MDR requirements. The HERA W10 and W9 are engineered for versatility in diagnostic imaging, with no specific MRI safety restrictions noted in the data. Storage and handling follow standard medical device protocols.

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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 specialties are the HERA W10 and W9 ultrasound systems primarily used for?

    The HERA W10 and W9 systems are designed for high-resolution imaging across multiple specialties, including obstetrics and gynecology, abdominal evaluations, cardiac assessments, and fluid analysis. Their real-time visualization capabilities make them versatile for clinical assessments in these areas, as noted in the device description.

  • Are the HERA W10 and W9 ultrasound systems single-use or reusable, and how should they be handled?

    The HERA W10 and W9 systems are reusable diagnostic ultrasound devices. They must be handled and stored according to standard medical device protocols, as specified in the device description, to ensure proper functionality and infection control.

  • What regulatory pathways have the HERA W10 and W9 ultrasound systems undergone, and which committee reviewed them?

    The HERA W10 and W9 systems have undergone FDA 510(k) clearance and EU MDR compliance. They were reviewed by the Radiology (RA) Advisory Committee under the product code IYN, as indicated in the specifications.

  • Do the HERA W10 and W9 ultrasound systems have any specific MRI safety restrictions?

    The provided data does not mention any specific MRI safety restrictions for the HERA W10 and W9 systems. However, standard medical device protocols should still be followed for safe handling in any clinical environment.