Sonosite Maxx Series Diagnostic Ultrasound System

• • Terminated Z-0057-2012 FDA Unclassified (pre-2012) ·initiated 18 Jul 2011 ·on shared 510(k) K071134

  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-2191-2010 FDA Unclassified (pre-2012) ·initiated 8 Aug 2008

  The TEE transesophageal transducer, when connected to a SonoSite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K071134 ↗

FDA Product Code

IYO

FDA applicant

Sonosite,Inc.

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Sonosite Hand-Caried Untrasound System (Powerseries)

  Class II

  FDA 510(k) K021628 Active Cleared 31 May 2002

• Sonosite Hand-Carried Ultrasound System

  Class II

  FDA 510(k) K010374 Active Cleared 21 Feb 2001

• C1 Ultrasound System

  Class II

  FDA 510(k) K990806 Active Cleared 26 Mar 1999

• Titan High Resolution Ultrasound System and Sonosite Ultrasound System

  Class II

  FDA 510(k) K043452 Active Cleared 21 Dec 2004

• Lumenvu Catheter Guidance System

  Class II

  FDA 510(k) K093510 Active Cleared 23 Aug 2010

• SonoHeart Hand-Carried Echocardiography System

  Class II

  FDA 510(k) K994096 Active Cleared 20 Dec 1999

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