Cleared Special

MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS

K063342 · Medrad, Inc. · Radiology
Nov 2006
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K063342 is an FDA 510(k) clearance for the MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on November 30, 2006, 24 days after receiving the submission on November 6, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K063342 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2006
Decision Date November 30, 2006
Days to Decision 24 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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