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WS80A Diagnostic Ultrasound System

by Samsung Medison Co., Ltd. 4 variants

510(k) K153529

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) K153529↗

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 NumberK153529 Date2 Feb 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-2276-2019 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  • Withdrawn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 WS80A Diagnostic Ultrasound System is a medical imaging device classified as a diagnostic ultrasound system, designed to produce real-time visual images of internal body structures using high-frequency sound waves. It enables clinicians to evaluate organs, tissues, and blood flow for diagnostic assessment, supporting a range of applications in radiology and general medical practice.

This system is intended for use in clinical settings by qualified medical personnel, adhering to standard operating procedures outlined in its user manual. Supplied as a reusable device, it requires proper maintenance and calibration to ensure accurate imaging performance. The WS80A holds FDA 510(k) clearance under the Traditional pathway and is compliant with MDR regulations, with an included identification label for traceability.

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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 types of clinical settings is the WS80A Diagnostic Ultrasound System intended for use in, and who should operate it?

    The WS80A is designed for clinical settings like radiology departments and general medical practices. It is meant to be used by qualified medical personnel, such as radiologists, sonographers, or other trained clinicians, who follow the standard operating procedures outlined in the device’s user manual to ensure proper and safe operation.

  • Is the WS80A a single-use or reusable device, and what maintenance is required to keep it functioning correctly?

    The WS80A is a reusable diagnostic ultrasound system. To maintain accurate imaging performance, it requires regular maintenance and calibration as specified in the manufacturer’s guidelines. Proper care and adherence to these procedures are essential for ensuring reliable operation over time.

  • How is the WS80A’s regulatory status defined, and what does this mean for its use in different markets?

    The WS80A holds FDA 510(k) clearance under the Traditional pathway, meaning it has been determined to be substantially equivalent to a legally marketed device. It is also compliant with the Medical Device Regulation (MDR) requirements, which ensures traceability through an included identification label. This regulatory status supports its use in markets where these clearances and compliance standards are recognized.

  • What does the product code (IYN) and advisory committee (RA) designation indicate about the WS80A’s classification and review process?

    The product code IYN categorizes the WS80A under the Radiology advisory committee (RA) in the FDA’s classification system. This indicates the device falls under the purview of radiology-related imaging technology, and its review was conducted by the Radiology Advisory Committee (RA) during the 510(k) clearance process. The Traditional pathway and SESE (Substantially Equivalent in Safety and Effectiveness) designation further confirm its alignment with existing ultrasound systems.