Cleared Special

3.0T PROSTATE IMAGING SYSTEM

K051349 · Medrad, Inc. · Radiology
Jun 2005
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K051349 is an FDA 510(k) clearance for the 3.0T PROSTATE IMAGING SYSTEM, 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 June 23, 2005, 30 days after receiving the submission on May 24, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K051349 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2005
Decision Date June 23, 2005
Days to Decision 30 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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