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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, Angiographic
510(k) Number K882358
Device Name PULSED FLUOROSCOPIC CONTROL MODEL:PF-02
Applicant
U.S. Imaging, Inc.
4816 Massillon Rd.
Greensburg,  OH  44232
Applicant Contact MARTIN J KULIS
Correspondent
U.S. Imaging, Inc.
4816 Massillon Rd.
Greensburg,  OH  44232
Correspondent Contact MARTIN J KULIS
Regulation Number892.1600
Classification Product Code
IZI  
Date Received06/07/1988
Decision Date 10/19/1988
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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