Cleared Traditional

K852865 - OPTICAL DISC UNIT

K852865 is the FDA 510(k) clearance for OPTICAL DISC UNIT by General Electric Co.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K852865 · General Electric Co. · Radiology device
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Oct 1985
Decision
94d
Days
Class 2
Risk

K852865 is an FDA 510(k) clearance for the OPTICAL DISC UNIT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on October 10, 1985 after a review of 94 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 K852865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1985
Decision Date October 10, 1985
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
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 604
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K852865.
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