Cleared Traditional

K921192 - CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM

K921192 is an FDA 510(k) clearance for CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM, 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 222-day FDA review.

K921192 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
222d
Days
Class 2
Risk

K921192 is an FDA 510(k) clearance for the CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM. 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 October 20, 1992 after a review of 222 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 GE Medical Systems devices

FDA 510(k) Submission Details - K921192

510(k) Number K921192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date October 20, 1992
Days to Decision 222 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
115d slower than avg
Panel avg: 107d · This submission: 222d
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 K921192.
HELICAT
K930090 · Elscint, Inc. · Mar 1993
PHILIPS TOMOSCAN SR7000 CT SYSTEMS
K924082 · Philips Medical Systems, Inc. · Mar 1993
ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
K923077 · GE Medical Systems · Feb 1993
WRIST RESTRAINT FOR GE9800 C.T. TABLES
K923108 · Cook, Inc. · Sep 1992
ADULT CHIN STRAP FOR CT TABLES
K923109 · Cook, Inc. · Sep 1992
SCAN BAND
K923110 · Cook, Inc. · Sep 1992