510(k) K113365

INFANT ARRAY by Advanced Imaging Research Dba Sree Medical Systems — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2012
Date Received
November 15, 2011
Clearance Type
Traditional
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