Cleared Special

HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

K052434 · GE Medical Systems · Radiology
Sep 2005
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K052434 is an FDA 510(k) clearance for the HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by GE Medical Systems (Tirat Hacarmel, IL). The FDA issued a Cleared decision on September 27, 2005, 21 days after receiving the submission on September 6, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K052434 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2005
Decision Date September 27, 2005
Days to Decision 21 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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