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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 K864046
Device Name C-IOO MOBILE CINE CT UNIT
Applicant
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Applicant Contact CYNTHIA L HAUGLAND
Correspondent
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Correspondent Contact CYNTHIA L HAUGLAND
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/16/1986
Decision Date 11/10/1986
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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