CT 9800

K841997 · General Electric Co. · JAK · Sep 4, 1984 · Radiology

Device Facts

Record IDK841997
Device NameCT 9800
ApplicantGeneral Electric Co.
Product CodeJAK · Radiology
Decision DateSep 4, 1984
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1750
Device ClassClass 2

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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