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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K828669
Device Name COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100
Applicant
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Correspondent
Imatron, Inc.
389 Oyster Pt. Blvd.
South San Fransisco,  CA  94080
Date Received11/30/1982
Decision Date 01/14/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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