510(k) K071611

NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL by Neocoil — Product Code MOS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2007
Date Received
June 13, 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