Cleared Special

8 CHANNEL CARDIAC PHASED ARRAY COIL

K032045 · GE Medical Systems · Radiology
Jul 2003
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K032045 is an FDA 510(k) clearance for the 8 CHANNEL CARDIAC PHASED ARRAY COIL, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on July 30, 2003, 28 days after receiving the submission on July 2, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K032045 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2003
Decision Date July 30, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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