GE Logiq P6

• • Terminated Z-0788-2019 FDA Class II ·initiated 28 Dec 2018

  Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.

• • Terminated Z-0834-2012 FDA Unclassified (pre-2012) ·initiated 23 Dec 2011

  GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators.

510(k) Number

K073297 ↗

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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