Cleared Special

K060401 - MEDRAD 3.0T ECOIL IMAGING SYSTEM
(FDA 510(k) Clearance)

K060401 · Medrad, Inc. · Radiology

Mar 2006

Decision

28d

Days

Class 2

Risk

K060401 is an FDA 510(k) clearance for the MEDRAD 3.0T ECOIL 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 March 15, 2006, 28 days after receiving the submission on February 15, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K060401 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2006
Decision Date	March 15, 2006
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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