510(k) K070629

FLEX AND LOOP COIL SET 1.5 T by Siemens Medical Solutions — Product Code MOS

K070629 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions for the device "FLEX AND LOOP COIL SET 1.5 T". The FDA issued a decision of Substantially Equivalent on March 26, 2007. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Siemens Medical Solutions has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2007
Date Received
March 7, 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