Cleared Traditional

K862317 - CT MAX, CATALOG NO. B7940 HA

K862317 is an FDA 510(k) clearance for CT MAX, manufactured by General Electric Co.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K862317 · General Electric Co. · Radiology device
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Oct 1986
Decision
111d
Days
Class 2
Risk

K862317 is an FDA 510(k) clearance for the CT MAX, CATALOG NO. B7940 HA. 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 7, 1986 after a review of 111 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

FDA 510(k) Submission Details - K862317

510(k) Number K862317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1986
Decision Date October 07, 1986
Days to Decision 111 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
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 732
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K862317.
CT PACE CATALOG NUMBER B7950A
K872526 · General Electric Co. · Sep 1987
CT9800 QUICK 3D #B7919DA
K871859 · General Electric Co. · Aug 1987
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935 · Toshiba Medical Systems · Dec 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · General Electric Co. · Aug 1986
TECHNICARE 720 HPS CT SCANNER
K854340 · Technicare Corp. · Nov 1985
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
K853444 · Toshiba Medical Systems · Nov 1985