510(k) K091546

NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 by Noras Mri Products GmbH — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2009
Date Received
May 27, 2009
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