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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K951261
Device Name DFI-1000 AND DVS-475 IMAGING DEVICES
Applicant
Nical
3 Hudson Ter.
Dobbs Ferry,  NY  10522
Applicant Contact GERALD SILVERMAN
Correspondent
Nical
3 Hudson Ter.
Dobbs Ferry,  NY  10522
Correspondent Contact GERALD SILVERMAN
Regulation Number892.1650
Classification Product Code
JAA  
Date Received03/21/1995
Decision Date 03/15/1996
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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