Cleared Traditional

K894269 - CT HILIGHT ADVANTAGE

K894269 is an FDA 510(k) clearance for CT HILIGHT ADVANTAGE, 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 71-day FDA review.

K894269 · GE Medical Systems · Radiology device
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Sep 1989
Decision
71d
Days
Class 2
Risk

K894269 is an FDA 510(k) clearance for the CT HILIGHT ADVANTAGE. 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 September 1, 1989 after a review of 71 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 - K894269

510(k) Number K894269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1989
Decision Date September 01, 1989
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
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 K894269.
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TE
K894888 · Shimadzu Medical Systems · Jan 1990
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TF
K894887 · Shimadzu Medical Systems · Dec 1989
ELSCINT'S EXEL 2400E CT SCANNER
K894542 · Elscint, Inc. · Sep 1989
CT SYTEC 3000
K893820 · General Electric Co. · Aug 1989
TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
K884555 · Toshiba Medical Systems · Feb 1989
TOSHIBA TCT-600XT COMPUTED TOMOGRAPHY X-RAY SYSTEM
K884788 · Toshiba Medical Systems · Feb 1989