Cleared Traditional

DIGITAL FLUOROGRAPHIC X-RAY SYSTEM (K802953) - FDA 510(k) Clearance

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

K802953 · General Electric Co. · Radiology device
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Jan 1981
Decision
50d
Days
Class 2
Risk

K802953 is an FDA 510(k) clearance for the DIGITAL FLUOROGRAPHIC X-RAY SYSTEM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 K802953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1980
Decision Date January 09, 1981
Days to Decision 50 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
57d faster than avg
Panel avg: 107d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 56
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K802953.
FLUORICON L300 IMAGE INTENSIFIER
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K811295 · Philips Medical Systems (Cleveland), Inc. · Jun 1981
SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
K801320 · General Electric Co. · Jul 1980
ORBITOR
K800639 · Philips Medical Systems (Cleveland), Inc. · May 1980
L/U ARM - NEURO - VASCULAR #B5080B
K791830 · General Electric Co. · Oct 1979