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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 K872615
Device Name IMATRON C-100 ULTRAFAST CT SCANNER
Applicant
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Applicant Contact CODUTO
Correspondent
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Correspondent Contact CODUTO
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/06/1987
Decision Date 09/23/1987
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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