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Sonosite Maxx Series Ultrasound System

by Sonosite, Inc.

510(k) K082098

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK082098 Date25 Aug 2008ClearedStatusActive

Recalls

2 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.

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  • Withdrawn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, 22 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 Maxx Series Ultrasound System is a software-controlled diagnostic ultrasound system designed for acquiring high-resolution, real-time ultrasound data using various transducers. It supports multiple imaging modes including 2D, M-Mode, Doppler variants, Elastography, and 3D flow imaging. The system is intended for diagnostic ultrasound procedures in clinical settings.

This portable, point-of-care ultrasound system is built for use in tight spaces and offers fast boot-up times, efficient power usage, and extended battery life. It is supplied as a single-unit system with hard-wired software for reliable performance. The device is intended for single-patient or multi-patient use with appropriate cleaning and disinfection between uses. Storage should follow manufacturer guidelines for temperature and humidity. The system is regulated under FDA 510(k) clearance with substantial equivalence determination.

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Questions

AI-generated answers, 22 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 applications is the Sonosite Maxx Series designed for?

    The Sonosite Maxx Series is designed for diagnostic ultrasound procedures in clinical settings. It supports multiple imaging modes including 2D, M-Mode, Doppler variants, Elastography, and 3D flow imaging, enabling a range of diagnostic assessments.

  • Is the Sonosite Maxx Series intended for single-patient or multi-patient use?

    The device is intended for both single-patient and multi-patient use, provided appropriate cleaning and disinfection protocols are followed between patients to maintain hygiene and prevent cross-contamination.

  • What imaging modes are supported by the Sonosite Maxx Series?

    The system supports 2D imaging, M-Mode, various Doppler modes, Elastography, and 3D flow imaging. These modes allow for comprehensive diagnostic ultrasound data acquisition across different clinical needs.

  • How is the Sonosite Maxx Series supplied and configured?

    The system is supplied as a single-unit, portable device with hard-wired software. This configuration ensures reliable performance, fast boot-up, efficient power usage, and extended battery life, making it suitable for tight spaces and point-of-care environments.

  • What storage conditions should be followed for the Sonosite Maxx Series?

    Storage should follow the manufacturer’s guidelines for temperature and humidity. Specific environmental parameters are provided by the manufacturer to ensure optimal device performance and longevity when not in use.