Cleared Traditional

CT/T 8800 (K812509) - FDA 510(k) Clearance

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

K812509 · General Electric Co. · Radiology device
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Oct 1981
Decision
41d
Days
Class 2
Risk

K812509 is an FDA 510(k) clearance for the CT/T 8800. 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 October 13, 1981 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 General Electric Co. devices

Submission Details

510(k) Number K812509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1981
Decision Date October 13, 1981
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.

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 K812509.
CT 9000
K843927 · General Electric Co. · Dec 1984
CT 9800
K841997 · General Electric Co. · Sep 1984
ARRANGE TM
K820688 · General Electric Co. · Mar 1982
CT/T 9800
K812241 · General Electric Co. · Sep 1981
CT/T DATALINK-B7875 AA/B7875 AB
K811227 · General Electric Co. · Jul 1981
DEHYDRATED BILE
K811358 · Acumedia Manufacturers, Inc. · May 1981