Cleared Traditional

SYNERGY HEAD/NECK COIL

K001331 · Philips Medical Systems North America, Inc. · Radiology
Jun 2000
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K001331 is an FDA 510(k) clearance for the SYNERGY HEAD/NECK COIL, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on June 9, 2000, 43 days after receiving the submission on April 27, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K001331 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2000
Decision Date June 09, 2000
Days to Decision 43 days
Submission Type Traditional
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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