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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 K031704
Device Name FILMLESS CLINIC
Applicant
Connect Imaging, Inc.
850 W. Hind Dr. # 214
Honolulu,  HI  96821
Applicant Contact PHILIP J MANLY
Correspondent
Connect Imaging, Inc.
850 W. Hind Dr. # 214
Honolulu,  HI  96821
Correspondent Contact PHILIP J MANLY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/02/2003
Decision Date 07/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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