Nemio Diagnostic Ultrasound System, Model Ssa-550A

• • Terminated Z-0253-2008 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.

510(k) Number

K043078 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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