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Sonoace 5500 Diagnostic Ultrasound System

by Medison America, Inc.

510(k) K992761

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 NumberK992761 Date1 Sep 1999ClearedStatusActive

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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Sonoace 5500 Diagnostic Ultrasound System is a diagnostic ultrasound system that acquires ultrasound data via piezoelectric transducers and displays B-mode, M-mode, and 3D images. It operates within a frequency range of 2.0-10.0 MHz. The system is designed to provide diagnostic ultrasound capabilities. It is a mobile, software-controlled system.

The Sonoace 5500 Diagnostic Ultrasound System is supplied with various transducers, including convex, endocavity, and linear designs. The system has been cleared under FDA 510(k) with the reference number K992761. It is intended for diagnostic use and is designed to be used in a clinical setting. The device is manufactured by Medison America, Inc.

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Questions

AI-generated answers, 28 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 Sonoace 5500 used for?

    The Sonoace 5500 is designed to provide diagnostic ultrasound capabilities in a clinical setting, allowing for the acquisition and display of ultrasound data via various transducers.

  • What types of transducers are supplied with the system?

    The system is supplied with convex, endocavity, and linear transducer designs, allowing for a range of diagnostic applications.

  • Is the Sonoace 5500 a mobile system?

    Yes, the Sonoace 5500 is a mobile, software-controlled system, making it convenient for use in various clinical settings.