Cleared Traditional

CT 9800 (K841997) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 351
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K841997.
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · General Electric Co. · Aug 1986
OPTICAL DISC UNIT
K852865 · General Electric Co. · Oct 1985
CT 9000
K843927 · General Electric Co. · Dec 1984
ARRANGE TM
K820688 · General Electric Co. · Mar 1982
CT/T 8800
K812509 · General Electric Co. · Oct 1981
CT/T 9800
K812241 · General Electric Co. · Sep 1981