Cleared Special

GE LOGIQ P6

K073297 · General Electric Co. · Radiology
Dec 2007
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K073297 is an FDA 510(k) clearance for the GE LOGIQ P6, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by General Electric Co. (Wauwatosa, US). The FDA issued a Cleared decision on December 18, 2007, 25 days after receiving the submission on November 23, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K073297 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2007
Decision Date December 18, 2007
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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