Sonosite Nanomaxx Series Ultrasound System

• • Terminated Z-0478-2011 FDA Unclassified (pre-2012) ·initiated 13 Aug 2010

  Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on the NanoMaxx ultrasound system results in errors when the "print" command is selected. As a result, the displayed MI or TI values may be incorrect.

• • 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.

510(k) Number

K092058 ↗

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

• 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

See all devices from Sonosite, Inc. →