Cleared Special

K052827 - MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
(FDA 510(k) Clearance)

K052827 · Medrad, Inc. · Radiology

Nov 2005

Decision

27d

Days

Class 2

Risk

K052827 is an FDA 510(k) clearance for the MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS, 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 1, 2005, 27 days after receiving the submission on October 5, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K052827 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 05, 2005
Decision Date	November 01, 2005
Days to Decision	27 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF