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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K962699
Device Name RADWORKS MEDICAL IMAGING SOFTWARE
Applicant
APPLICARE MEDICAL IMAGING, B.V.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE,  MD  20852
Applicant Contact ROBERT L SHERIDAN
Correspondent
APPLICARE MEDICAL IMAGING, B.V.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE,  MD  20852
Correspondent Contact ROBERT L SHERIDAN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received07/11/1996
Decision Date 08/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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