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Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)

by Sonosite, Inc.

510(k) K043559

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK043559 Date12 Jan 2005ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0057-2012 FDA Unclassified (pre-2012) initiated 18 Jul 2011

    This is a software anomaly. In some circumstances, if the Systolic/Diastolic (S/D) ratio value is interpreted directly from the display, the clinician could potentially use an incorrect value of the S/D ratio in his/her assessment.

    • Terminated Z-2654-2010 FDA Unclassified (pre-2012) initiated 2 Nov 2007

    Sterilization of the SonoSite LAP surgical Transducer with the Sterrad NX System may result in damage to the transducer.

    • Terminated Z-2655-2010 FDA Unclassified (pre-2012) initiated 2 Nov 2007

    Sterilization of the SonoSite SLT ultrasound surgical transducer with the Sterrad NX System may result in damage to the transducer.

    • Terminated Z-0661-2007 FDA Unclassified (pre-2012) initiated 5 Feb 2007

    Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.

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  • Withdrawn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
FDA applicant
Sonosite,Inc.
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) is a software-controlled diagnostic ultrasound system that utilizes piezoelectric transducers to transmit ultrasound energy into the body and receive reflected signals. It is designed for diagnostic imaging applications.

This system is used in radiology settings and has received FDA 510(k) clearance under K-number K043559, issued in 2005. It is manufactured by Sonosite, Inc. and classified as a Class II ultrasound system.

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Questions

AI-generated answers, 27 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 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) used for?

    It is designed for diagnostic imaging applications in radiology settings, using piezoelectric transducers to transmit and receive ultrasound energy for creating diagnostic images of internal body structures.

  • How is the Sonosite C3 Series ultrasound system supplied and powered?

    It is a software-controlled diagnostic ultrasound system that operates using electrical power and is designed for use in clinical environments such as radiology departments, where it processes signals from connected piezoelectric transducers to generate images.

  • Is the Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) a single-use or reusable device?

    It is a reusable diagnostic ultrasound system intended for repeated clinical use; the main unit and transducers are designed to be cleaned and disinfected between uses according to manufacturer guidelines, not disposed of after a single procedure.