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Sonosite MicroMaxx Diagnostic Ultrasound System C3 Series

by Sonosite, Inc.

510(k) K053069

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK053069 Date16 Nov 2005ClearedStatusActive

Recalls

3 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-2116-2010 FDA Unclassified (pre-2012) initiated 27 May 2010

    PowerPark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.

    • 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  • Withdrawn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, 26 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 MicroMaxx Diagnostic Ultrasound System C3 Series is a software-controlled diagnostic ultrasound system. It utilizes piezoelectric transducers to transmit ultrasound energy into the body and receive reflected signals for diagnostic imaging.

This system is supplied for use in clinical settings and is subject to FDA 510k authorization. Users should refer to the system user guide for instructions on preparation, operation, system upgrades, and the cleaning and disinfection of transducers.

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Questions

AI-generated answers, 26 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 primary function of the Sonosite MicroMaxx C3 Series?

    The MicroMaxx C3 Series is a software-controlled diagnostic ultrasound system designed for use in clinical settings. It functions by transmitting ultrasound energy into the body via piezoelectric transducers and processing the reflected signals to generate diagnostic images.

  • How should users maintain the system and its transducers?

    Users must consult the official system user guide for all operational requirements. This includes specific instructions regarding system preparation, routine operation, performing system upgrades, and the necessary procedures for the cleaning and disinfection of the transducers to ensure clinical safety.

  • What is the regulatory status of this ultrasound system?

    The Sonosite MicroMaxx Diagnostic Ultrasound System C3 Series is subject to FDA 510k authorization. It was reviewed under the radiology advisory committee and determined to be substantially equivalent to existing devices, as indicated by the K053069 submission.