Cleared Traditional

K842184 - SPOT-FILM DEVICE 8835

K842184 is the FDA 510(k) clearance for SPOT-FILM DEVICE 8835 by General Electric Co.. It is a Class 2 Radiology device (product code IXL) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K842184 · General Electric Co. · Radiology device
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Jul 1984
Decision
46d
Days
Class 2
Risk

K842184 is an FDA 510(k) clearance for the SPOT-FILM DEVICE 8835. Classified as Device, Spot-film (product code IXL), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1984 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1670 - 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 K842184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1984
Decision Date July 17, 1984
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXL Device, Spot-film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1670
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 - IXL Device, Spot-film

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