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Sonoscape Ultrasound System and Transducers Model SSI-8000, 2P1 Phased Array, 5P1 Phased Array Model 2P1, 5P1, 6V1 Micro - 2P1 Phased Array

by Sonoscape Company Limited

510(k) K102642

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK102642 Date4 Mar 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYN
Models / Variants
2P1 Phased Array
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Sonoscape Ultrasound System and Transducers Model SSI-8000 is a trolley-based ultrasound color Doppler system that includes multiple phased array transducers (2P1, 5P1) and a micro convex transducer (6V1). This system is designed for professional cardiac applications and provides high-density digital beamforming technology with multiple processor operation.

The system is supplied with various transducer models including 2P1, 5P1, and 6V1 micro, and is intended for use in medical imaging settings. It received FDA 510(k) clearance with decision code SESE on March 4, 2011, and is classified under product code IYN. The device is not specified as single-use or reusable, and no MRI safety information is provided.

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Questions

AI-generated answers, 25 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 is the Sonoscape SSI-8000 Ultrasound System used for?

    The Sonoscape SSI-8000 is a trolley-based ultrasound color Doppler system designed specifically for professional cardiac applications, featuring high-density digital beamforming technology with multiple processor operation.

  • What transducers are included with the Sonoscape SSI-8000 system?

    The system is supplied with multiple phased array transducers including 2P1, 5P1, and a micro convex transducer model 6V1, each designed for different cardiac imaging applications.

  • Is the Sonoscape SSI-8000 system single-use or reusable?

    The device data does not specify whether the Sonoscape SSI-8000 system or its transducers are single-use or reusable, indicating this information should be obtained directly from the manufacturer.

  • What regulatory clearance has the Sonoscape SSI-8000 received?

    The Sonoscape SSI-8000 received FDA 510(k) clearance with decision code SESE on March 4, 2011, and is classified under product code IYN, indicating it is substantially equivalent to predicate devices.