Cleared Traditional

CT PACE CATALOG NUMBER B7950A (K872526) - FDA 510(k) Clearance

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

K872526 · General Electric Co. · Radiology device
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Sep 1987
Decision
90d
Days
Class 2
Risk

K872526 is an FDA 510(k) clearance for the CT PACE CATALOG NUMBER B7950A. 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 September 23, 1987 after a review of 90 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 K872526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1987
Decision Date September 23, 1987
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 351
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K872526.
CT MAX 640 #B7940 JA/JE
K882581 · General Electric Co. · Aug 1988
XENON CT
K875088 · Siemens Medical Solutions USA, Inc. · Jul 1988
SOMATOM PLUS
K880965 · Siemens Medical Solutions USA, Inc. · Mar 1988
CT9800 QUICK 3D #B7919DA
K871859 · General Electric Co. · Aug 1987
CT MAX, CATALOG NO. B7940 HA
K862317 · General Electric Co. · Oct 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · General Electric Co. · Aug 1986