HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4


Device Classification Name

system, tomography, computed, emission

510(k) Number K021656
Device Name HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4
Original Applicant
NUCLEAR DIAGNOSTICS
soder malarstrand 13
stockholm, 

SE

118 20

Original Contact jan bertling
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 05/20/2002
Decision Date 06/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No