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RS80 EVO Diagnostic Ultrasound System

by Samsung Medison Co., Ltd.

510(k) K192030

Active European Union and United States. Also listed in GUDID (US).

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) K192030↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08809521024470 UDI-DI Date10 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK192030 Date19 Sep 2019ClearedStatusActive
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  • Withdrawn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) · GUDID

Generic Name
General-purpose ultrasound imaging system
Model / Reference
USS-RS8EF40/WR
Primary DI / UDI-DI
08809521024470
510(k) Number
FDA Product Code
IYN, ITX, IYO
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation
21 CFR Part 892.1550 510(k)GUDID
892.1570 GUDID
892.1560 GUDID
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

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 RS80 EVO Diagnostic Ultrasound System is a diagnostic imaging device classified as an ultrasound system, designed to produce real-time visual images of internal body structures using high-frequency sound waves. It supports a range of applications, including abdominal, obstetric, gynecological, vascular, and musculoskeletal imaging, enabling clinicians to assess organ function, blood flow, and tissue morphology.

This system is supplied as a reusable medical device and is intended for use in clinical, hospital, or diagnostic imaging settings. It operates under sterile conditions when used for invasive procedures and is compatible with MRI environments as specified by its design. The device is authorised under FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for diagnostic imaging equipment. Storage and maintenance follow manufacturer guidelines to preserve performance and imaging accuracy.

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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 medical imaging procedures can the RS80 EVO Diagnostic Ultrasound System support in clinical settings?

    The RS80 EVO Diagnostic Ultrasound System is designed for a broad range of diagnostic imaging applications, including abdominal, obstetric, gynecological, vascular, and musculoskeletal studies. Its high-frequency sound wave technology allows clinicians to visualize internal structures in real-time, making it versatile for assessing organ function, blood flow, and tissue morphology across these specialties.

  • Is the RS80 EVO Diagnostic Ultrasound System intended for single-use or reusable applications, and how should it be maintained?

    The RS80 EVO is supplied as a reusable medical device, meaning it is built for repeated use in clinical, hospital, or diagnostic imaging environments. Proper maintenance and adherence to the manufacturer’s guidelines are essential to preserve performance and imaging accuracy. Sterile conditions must be maintained when the device is used for invasive procedures.

  • Can the RS80 EVO Diagnostic Ultrasound System be used in an MRI environment, and what regulatory compliance does it meet?

    Yes, the RS80 EVO is designed to be MRI-compatible, meaning it can be safely used in environments where MRI procedures are performed, provided it adheres to the manufacturer’s specified guidelines. Regulatory compliance includes FDA 510(k) clearance (K192030, Substantially Equivalent under the Radiology Advisory Committee) and MDR compliance, ensuring it meets stringent diagnostic imaging standards.

  • How should the RS80 EVO Diagnostic Ultrasound System be stored to ensure optimal performance?

    The RS80 EVO requires storage and maintenance following the manufacturer’s guidelines to maintain imaging accuracy and device functionality. While specific storage conditions (e.g., temperature, humidity, or environmental protection) are not detailed here, proper handling—including protection from physical damage and contamination—is critical. Always refer to the manufacturer’s instructions for precise storage protocols.

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No