Cleared Traditional

K841997 - CT 9800

K841997 is an FDA 510(k) clearance for CT 9800, 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 111-day FDA review.

K841997 · General Electric Co. · Radiology device
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Sep 1984
Decision
111d
Days
Class 2
Risk

K841997 is an FDA 510(k) clearance for the CT 9800. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 111 days - within the typical 510(k) review window.

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 - K841997

510(k) Number K841997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1984
Decision Date September 04, 1984
Days to Decision 111 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
4d slower than avg
Panel avg: 107d · This submission: 111d
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 K841997.
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
K853444 · Toshiba Medical Systems · Nov 1985
OPTICAL DISC UNIT
K852865 · General Electric Co. · Oct 1985
CT 9000
K843927 · General Electric Co. · Dec 1984
CENTAURI CT SCANNER
K840860 · Technicare Corp. · May 1984
ARRANGE TM
K820688 · General Electric Co. · Mar 1982
IMAGE ANALYSIS CENTER
K813196 · Technicare Corp. · Dec 1981