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S9 Portable Digital Color Doppler Ultrasound System

by Sonoscape Medical Corp.

510(k) K152165

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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152165↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK152165 Date26 Aug 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2110-2014 FDA Class II initiated 9 Jul 2014 on shared 510(k) K152165
    • Terminated Z-2109-2014 FDA Class II initiated 9 Jul 2014 on shared 510(k) K152165

    The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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 S9 Portable Digital Color Doppler Ultrasound System is a portable diagnostic imaging device classified as a color Doppler ultrasound machine (Device Type: IYN). It combines real-time ultrasound imaging with color Doppler functionality to visualize blood flow within vessels and organs, aiding in the assessment of vascular conditions, organ perfusion, and other circulatory evaluations. The system is designed for handheld or portable use, enabling versatile deployment in clinical, emergency, and field settings.

This device is supplied as a reusable medical instrument, requiring appropriate cleaning, disinfection, and maintenance per manufacturer guidelines. It is intended for use in MRI-unsafe environments due to its electronic and electromagnetic components. The system is authorized under FDA 510K clearance (K152165) and MDR compliance, with regulatory submissions filed under the Radiology Advisory Committee. Storage and handling must adhere to sterile or aseptic protocols when used in invasive procedures, though the device itself is not single-use.

Other devices from Sonoscape Medical Corp.

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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.

  • Is the S9 Portable Digital Color Doppler Ultrasound System designed for single-use or can it be reused in clinical settings?

    The S9 is a reusable medical instrument, not intended for single-use. It requires proper cleaning, disinfection, and maintenance following the manufacturer’s guidelines to ensure safe and effective operation across multiple uses. While the device itself is not sterile, sterile or aseptic protocols must be followed when used in invasive procedures to maintain patient safety.

  • Can this device be used in environments where MRI machines are present, or is it safe only in non-MRI areas?

    The S9 is explicitly designed for use in MRI-unsafe environments due to its electronic and electromagnetic components. Its handheld and portable nature makes it suitable for clinical, emergency, or field settings where MRI compatibility is a concern, but it should never be used near active MRI systems.

  • What types of vascular or circulatory evaluations can this device assist with, and how does the color Doppler feature help?

    The S9 combines real-time ultrasound imaging with color Doppler functionality, allowing clinicians to visualize blood flow within vessels and organs. This aids in assessing vascular conditions (e.g., stenosis, blockages), organ perfusion, and circulatory health by highlighting areas of abnormal flow patterns or turbulence that may not be visible with standard ultrasound alone.

  • How is the device supplied, and what storage or handling precautions should be taken?

    The S9 is supplied as a reusable system, meaning it must be cleaned, disinfected, and maintained per manufacturer instructions between uses. While the device itself is not sterile, if used in invasive procedures, sterile or aseptic protocols must be followed to prevent contamination. Storage should comply with manufacturer guidelines to preserve functionality and ensure longevity.

  • What regulatory pathways does this device follow, and which advisory committee was involved in its clearance?

    The S9 received FDA 510K clearance (K152165) under the Radiology Advisory Committee (RA), with a decision classified as *Substantially Equivalent (SESE)*. It also complies with MDR (Medical Device Regulation) requirements. The device’s regulatory submission was filed under the product code IYN (Color Doppler Ultrasound Machine) and was reviewed as a *Special* clearance type.