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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K022395
Device Name 1.5T SCANMED PV ARRAY
Applicant
MEDIC, INC.
6912 NORTH 97TH CIRCLE,
SUITE C
OMAHA,  NE  68122
Applicant Contact RANDALL W JONES
Correspondent
MEDIC, INC.
6912 NORTH 97TH CIRCLE,
SUITE C
OMAHA,  NE  68122
Correspondent Contact RANDALL W JONES
Regulation Number892.1000
Classification Product Code
MOS  
Date Received07/23/2002
Decision Date 08/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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