510(k) K072909

1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL by Siemens AG Medical Solutions — Product Code MOS

K072909 is an FDA 510(k) premarket notification submitted by Siemens AG Medical Solutions for the device "1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL". The FDA issued a decision of Substantially Equivalent on October 31, 2007. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Siemens AG Medical Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2007
Date Received
October 12, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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