Skip to content

HERA W10 Diagnostic Ultrasound System

by Samsung Medison Co., Ltd.

510(k) K182595

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) K182595↗

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 NumberK182595 Date18 Dec 2018ClearedStatusActive
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  • Withdrawn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 Hera W10 Diagnostic Ultrasound System is a diagnostic imaging device classified as a diagnostic ultrasound system. 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.

This system is supplied as a reusable medical device and is intended for use in clinical settings such as hospitals, diagnostic imaging centers, and outpatient clinics. It is regulated under FDA 510K clearance and MDR compliance, with a Traditional clearance pathway through the Radiology Advisory Committee (RA). The device is designed for professional medical use and requires proper training for operation.

Other devices from Samsung Medison Co., Ltd.

See all devices from Samsung Medison Co., Ltd. →

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.

  • Is the HERA W10 Diagnostic Ultrasound System designed for single-use or can it be reused in clinical settings?

    The HERA W10 is explicitly supplied as a reusable medical device, intended for professional use in clinical settings like hospitals and diagnostic centers. Since it is not labeled as disposable, it must be properly cleaned, disinfected, and maintained between uses to ensure safety and performance, following manufacturer guidelines and facility protocols.

  • What types of clinical environments is the HERA W10 Diagnostic Ultrasound System intended for?

    The device is designed for clinical settings such as hospitals, diagnostic imaging centers, and outpatient clinics. Its classification as a reusable diagnostic ultrasound system suggests it is meant for routine, professional use where multiple patients may be assessed over time, requiring durable equipment that can be maintained and serviced.

  • How is the regulatory pathway for the HERA W10 Diagnostic Ultrasound System structured, and what does that mean for buyers?

    The device was cleared through the FDA’s 510(k) pathway, specifically under a Traditional clearance with the Radiology Advisory Committee (RA). This means it was determined to be substantially equivalent to a legally marketed predicate device, and buyers can rely on this pathway as evidence of its safety and effectiveness for diagnostic ultrasound imaging purposes, as defined by the FDA’s regulatory standards.

  • What does the MDR compliance label on the HERA W10 Diagnostic Ultrasound System indicate for international buyers?

    The MDR (Medical Device Regulation) compliance designation confirms the device meets European Union requirements for safety, performance, and risk management as outlined in the MDR framework. For international buyers, this indicates the system adheres to stringent EU standards, which may simplify market access in regions where MDR compliance is a prerequisite for sale or use.

  • What should buyers consider regarding the training requirements for operating the HERA W10 Diagnostic Ultrasound System?

    The device is explicitly designed for professional medical use, which implies that operators must undergo proper training to ensure accurate imaging and safe operation. Buyers should verify that their staff are trained in ultrasound technology, including system-specific protocols for the HERA W10, as well as any facility-specific procedures for maintenance and sterilization (where applicable). Manufacturer training resources or partnerships may be available to support this.