510(k) K063373

FLEX LOOP COIL SET 3T by Siemens AG — Product Code MOS

K063373 is an FDA 510(k) premarket notification submitted by Siemens AG for the device "FLEX LOOP COIL SET 3T". The FDA issued a decision of Substantially Equivalent on November 17, 2006. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Siemens AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2006
Date Received
November 8, 2006
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