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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K002782
Device Name HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
Applicant
Nuclear Diagnostics AB
11800 Baltimore Ave.
Suite 105
Beltsville,  MD  20705
Applicant Contact JIM HOWARD
Correspondent
Nuclear Diagnostics AB
11800 Baltimore Ave.
Suite 105
Beltsville,  MD  20705
Correspondent Contact JIM HOWARD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/06/2000
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
Predetermined Change
Control Plan Authorized		 No
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