510(k) K063342

MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS by Medrad, Inc. — Product Code MOS

K063342 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS". The FDA issued a decision of Substantially Equivalent on November 30, 2006. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Medrad, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2006
Date Received
November 6, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coil, Magnetic Resonance, Specialty
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type