Cleared Traditional

K861708 - SOLID STATE DETECTOR COMPUTERIZED TOMOG...

K861708 is the FDA 510(k) clearance for SOLID STATE DETECTOR COMPUTERIZED TOMOG... by General Electric Co.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K861708 · General Electric Co. · Radiology device
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Aug 1986
Decision
116d
Days
Class 2
Risk

K861708 is an FDA 510(k) clearance for the SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC. 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 August 29, 1986 after a review of 116 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 K861708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1986
Decision Date August 29, 1986
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
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 K861708.
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K871859 · General Electric Co. · Aug 1987
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OPTICAL DISC UNIT
K852865 · General Electric Co. · Oct 1985