HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION


Device Classification Name

system, image processing, radiological

510(k) Number K002782
Device Name HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
Original Applicant
NUCLEAR DIAGNOSTICS AB
11800 baltimore ave.
suite 105
beltsville, 
MD 
20705

Original Contact jim howard
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/06/2000
Decision Date 12/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No