Nemio Xg, Saa-580A

• • Terminated Z-0254-2008 FDA Unclassified (pre-2012) ·initiated 29 Aug 2007

  Multiple problems including : (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

• • Terminated Z-0771-2007 FDA Unclassified (pre-2012) ·initiated 19 Dec 2006 ·on shared 510(k) K061605

  Transducer Surface Temperature : It was found during testing that when using the system in the 2DCDI + PW mode, with the Scale Graph function active, that the transducer surface temperature could exceed the 27 degrees Celsius limit as specified in the IEC safety standard.

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

510(k) Number

K061605 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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