Cleared Special

EXTRA LARGE BODY COIL

K023442 · GE Medical Systems · Radiology
Nov 2002
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K023442 is an FDA 510(k) clearance for the EXTRA LARGE BODY 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 November 5, 2002, 21 days after receiving the submission on October 15, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K023442 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2002
Decision Date November 05, 2002
Days to Decision 21 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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