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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 K852346
Device Name XISCAN MODEL 1000
Applicant
Xi Tech
215 - Rte. 10
Randolph,  NJ  07869
Applicant Contact PETER TOBIA
Correspondent
Xi Tech
215 - Rte. 10
Randolph,  NJ  07869
Correspondent Contact PETER TOBIA
Regulation Number892.1650
Classification Product Code
JAA  
Date Received05/31/1985
Decision Date 03/10/1986
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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