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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 K854810
Device Name FC-1000 FLUOROSCOPIC IMAGING COMPUTER
Applicant
Inficon Leybold-Heraeus, Inc.
6500 Fly Rd.
East Syracuse,  NY  13057
Applicant Contact JOHN G STRATAKOS
Correspondent
Inficon Leybold-Heraeus, Inc.
6500 Fly Rd.
East Syracuse,  NY  13057
Correspondent Contact JOHN G STRATAKOS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/03/1985
Decision Date 04/15/1986
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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