HERMES MEDICAL IMAGING SUITE V5.2


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

Correspodent Contact joakim arwidson
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 04/30/2012
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