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S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System

by Sonoscape Medical Corp.

510(k) K152164

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152164↗

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 NumberK152164 Date28 Aug 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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 S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System is a portable diagnostic imaging device classified as a Color Doppler Ultrasound System. 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 cardiovascular evaluations.

This system is designed for use in clinical, outpatient, and emergency settings, providing portable diagnostic capabilities for healthcare professionals. Supplied as a reusable device, it requires appropriate sterilization or disinfection protocols between uses. The system is authorized under FDA 510K clearance and MDR compliance, ensuring adherence to regulatory standards for medical imaging equipment. Its portability and advanced imaging features make it suitable for diverse clinical environments, including remote or resource-limited settings.

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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 clinical settings is this ultrasound system designed for and how does its portability benefit users?

    The S8 Exp/S9 Pro is specifically designed for use in clinical, outpatient, and emergency settings, offering flexibility for healthcare professionals. Its portability allows for diagnostic imaging in diverse environments, including remote or resource-limited locations, reducing the need for patients to travel to fixed imaging facilities. This is particularly useful in situations where quick assessments are required, such as emergency departments or field settings.

  • Is this device single-use or reusable, and what cleaning or sterilization steps are required?

    The S8 Exp/S9 Pro is a reusable device, meaning it is intended for multiple uses across different patients. Since it is reusable, it must undergo appropriate sterilization or disinfection protocols between uses to ensure patient safety and device functionality. The manufacturer recommends following standard clinical guidelines for cleaning and sterilizing ultrasound equipment to maintain hygiene and performance.

  • How does the regulatory approval process for this device ensure its safety and effectiveness?

    This device holds both FDA 510K clearance and MDR compliance, indicating it has undergone rigorous review by regulatory authorities. The FDA 510K clearance process compares the device to a previously approved predicate, ensuring it is substantially equivalent in terms of safety and performance. Meanwhile, MDR compliance aligns with European medical device regulations, reinforcing its adherence to stringent safety and quality standards. Both approvals help guarantee that the device meets global regulatory expectations for medical imaging equipment.

  • What types of evaluations can this ultrasound system perform, and why is color Doppler functionality important?

    The S8 Exp/S9 Pro combines real-time ultrasound imaging with color Doppler functionality, enabling it to visualize blood flow within vessels and organs. This is critical for assessing vascular conditions, organ perfusion, and cardiovascular evaluations. Color Doppler adds a visual representation of blood flow direction and velocity, helping clinicians identify abnormalities like blockages, stenosis, or inadequate perfusion that might not be visible with traditional ultrasound alone.