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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K121278
Device Name HERMES MEDICAL IMAGING SUITE V5.2
Applicant
HERMES MEDICAL SOLUTIONS, AB
SKEPPSBRON 44
STOCKHOLM,  SE 111 30
Applicant Contact JOAKIM ARWIDSON
Correspondent
HERMES MEDICAL SOLUTIONS, AB
SKEPPSBRON 44
STOCKHOLM,  SE 111 30
Correspondent Contact JOAKIM ARWIDSON
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/30/2012
Decision Date 12/18/2012
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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