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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, Tomography, Computed
510(k) Number K861698
Device Name VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400
Applicant
Visiscan
16540 Aston St.
Irvine,  CA  92714
Applicant Contact KENNETH GORSKE
Correspondent
Visiscan
16540 Aston St.
Irvine,  CA  92714
Correspondent Contact KENNETH GORSKE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/05/1986
Decision Date 10/03/1986
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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