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RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System

by Samsung Medison Co., Ltd. 2 variants

510(k) K210959

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) K210959↗

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 NumberK210959 Date24 Jun 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  • Withdrawn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 RS85 and RS80 EVO are portable diagnostic ultrasound systems designed for real-time imaging of internal body structures using high-frequency sound waves. These devices provide visual guidance for diagnostic and interventional procedures, supporting applications in obstetrics, cardiology, abdominal, vascular, and musculoskeletal assessments.

Supplied as reusable medical equipment, these systems are intended for use in clinical settings such as hospitals, diagnostic imaging centers, and emergency departments. The RS85 and RS80 EVO comply with FDA 510(k) clearance under the Radiology Advisory Committee and EU MDR, featuring standardised connectivity and imaging protocols for regulatory and operational integration. Storage and handling follow manufacturer guidelines to maintain performance and sterility of transducers when used in reusable configurations.

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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.

  • Are the RS85 and RS80 EVO ultrasound systems designed for single-use or reusable applications, and what does that mean for maintenance and cleaning?

    The RS85 and RS80 EVO are reusable medical devices, meaning they are built for repeated use in clinical settings like hospitals and imaging centers. Since they are not single-use, proper cleaning, disinfection, and maintenance are required between procedures to ensure hygiene and functionality. The manufacturer provides guidelines for storage and handling to maintain performance, particularly for the transducers, which are the disposable or reusable components that interface with patients.

  • What types of medical procedures or assessments can these ultrasound systems support, and why are they considered portable?

    These systems are designed for real-time imaging of internal structures and can support diagnostic and interventional procedures across multiple specialties, including obstetrics, cardiology, abdominal, vascular, and musculoskeletal assessments. They are classified as portable, meaning they can be easily moved between locations—such as from an emergency department to an operating room—making them versatile for dynamic clinical environments where mobility is advantageous.

  • How do the RS85 and RS80 EVO comply with regulatory standards, and what does the ‘Radiology Advisory Committee’ classification mean for their use?

    Both systems hold FDA 510(k) clearance under the Radiology Advisory Committee (RA), confirming they meet U.S. regulatory requirements for diagnostic ultrasound devices. The classification under the Radiology committee indicates these devices are intended for imaging and procedural guidance, not therapeutic use. Additionally, they comply with the EU Medical Device Regulation (MDR), ensuring they meet stringent safety, performance, and traceability standards for use across Europe.

  • What are the key differences between the RS85 and RS80 EVO models, and how might a clinician choose between them?

    While the exact technical distinctions between the RS85 and RS80 EVO are not detailed in the provided data, both are portable diagnostic ultrasound systems with similar core functionalities. The choice between them likely depends on factors like specific imaging protocols, connectivity standards, or performance enhancements tailored to a clinic’s workflow. Since both are cleared under the same regulatory pathway (FDA 510(k) and MDR), compatibility with existing systems and clinical needs would be the primary considerations for selection.