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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 K972879
Device Name ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION
Applicant
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Applicant Contact J. A. CODUTO
Correspondent
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Correspondent Contact J. A. CODUTO
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/05/1997
Decision Date 10/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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