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RS85 Diagnostic Ultrasound System

by Samsung Medison Co., Ltd. 5 variants

510(k) K240516

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) K240516↗

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 NumberK240516 Date12 Jun 2024ClearedStatusActive
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  • Withdrawn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 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 supports a range of applications, including obstetrics, cardiology, abdominal, vascular, and musculoskeletal imaging, enabling clinicians to diagnose and monitor conditions with enhanced precision and detail.

This system is supplied as a reusable, non-sterile medical device intended for use in clinical, hospital, and diagnostic imaging settings. It is regulated under FDA 510(k) clearance (K240516) and EU MDR compliance, with no third-party involvement in the submission process. The device is manufactured by Samsung Medison Co., Ltd., and includes standard features for diagnostic ultrasound imaging, though specific sterility, MRI safety, or size variations are not detailed in the provided data.

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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 applications is the RS85 Diagnostic Ultrasound System primarily used for?

    The RS85 Diagnostic Ultrasound System is designed for a broad range of clinical applications, including obstetrics (e.g., prenatal imaging), cardiology (heart imaging), abdominal scans (e.g., liver or kidney assessment), vascular studies (blood flow and vessel evaluation), and musculoskeletal imaging (e.g., joints or soft tissues). Its real-time imaging capability allows clinicians to diagnose and monitor conditions with detailed visualization of internal structures.

  • Is the RS85 Diagnostic Ultrasound System intended for single-use or reusable in clinical settings?

    The RS85 is supplied as a reusable device, meaning it is intended for repeated use in clinical, hospital, or diagnostic imaging environments. Since it is non-sterile, proper cleaning, disinfection, and maintenance protocols must be followed per facility guidelines to ensure safe and effective operation across multiple patients.

  • How is the regulatory pathway for the RS85 Diagnostic Ultrasound System defined, and what does that mean for buyers?

    The RS85 was cleared via the FDA 510(k) pathway (K240516) under the Traditional review process, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended purpose and technological characteristics as a previously cleared ultrasound system. For buyers, this indicates the device meets U.S. regulatory standards for safety and effectiveness, though local compliance (e.g., FDA registration, state licensing) remains the purchaser’s responsibility. It also complies with EU MDR, ensuring alignment with European market requirements.

  • Who is the manufacturer of the RS85 Diagnostic Ultrasound System, and where is it based?

    The RS85 Diagnostic Ultrasound System is manufactured by Samsung Medison Co., Ltd., a company headquartered in Hanseo-Ro, Nam-Myeon, Hongcheon-Gun, South Korea (postal code 25108). For inquiries or support, buyers may contact the manufacturer directly via the provided address or contact details (e.g., So-Yeon Jang).