Cleared Traditional

K913485 - CT SYTEC 8000

K913485 is an FDA 510(k) clearance for CT SYTEC 8000, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K913485 · General Electric Co. · Radiology device
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Jan 1992
Decision
170d
Days
Class 2
Risk

K913485 is an FDA 510(k) clearance for the CT SYTEC 8000. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on January 23, 1992 after a review of 170 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all General Electric Co. devices

FDA 510(k) Submission Details - K913485

510(k) Number K913485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date January 23, 1992
Days to Decision 170 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 107d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 732
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K913485.
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
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SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
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COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K913996 · Siemens Medical Solutions USA, Inc. · Nov 1991
GYROVIEW-HR
K913029 · Philips Medical Systems, Inc. · Oct 1991
KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
K912454 · Eastman Kodak Company · Sep 1991