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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K943602
Device Name DI-2000
Applicant
Miles Inc., Agfa Division
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Applicant Contact MICHAEL SULLIVAN
Correspondent
Miles Inc., Agfa Division
100 Challenger Rd.
Ridgefield Park,  NJ  07660
Correspondent Contact MICHAEL SULLIVAN
Regulation Number892.1100
Classification Product Code
IYX  
Date Received07/25/1994
Decision Date 05/12/1995
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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