FDA 510(k) Review, K911387 , CT SYTEC 4000, by GE Medical Systems
FDA 510(k) Review, K911387 , CT SYTEC 4000, by GE Medical Systems
NOTE: Review Document Only
Device Classification Name: System, X-Ray, Tomography, Computed
510(k) Number: K911387
Device Name: CT SYTEC 4000
Applicant: GE Medical Systems
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 03/29/1991
Decision Date: 05/09/1991
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology
Total number of pages: 2
Fully redacted pages: 0
Content pages: 2
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