Cleared Traditional

K911387 - CT SYTEC 4000

K911387 is an FDA 510(k) clearance for CT SYTEC 4000, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K911387 · GE Medical Systems · Radiology device
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May 1991
Decision
41d
Days
Class 2
Risk

K911387 is an FDA 510(k) clearance for the CT SYTEC 4000. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on May 9, 1991 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems devices

FDA 510(k) Submission Details - K911387

510(k) Number K911387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date May 09, 1991
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 107d · This submission: 41d
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 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K911387.
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
K911500 · Shimadzu Medical Systems · Jul 1991
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
K911501 · Shimadzu Medical Systems · Jul 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
K910859 · Siemens Medical Solutions USA, Inc. · May 1991
HELICAL SCAN
K910375 · Toshiba America Medical Systems, In.C · Mar 1991
CT HILIGHT ADVANTAGE II
K904971 · GE Medical Systems · Jan 1991
XPRESS
K903701 · Toshiba America Medical Systems, In.C · Nov 1990