Cleared Traditional

K870400 - SCX INFORMATION MANAGEMENT SYSTEM

K870400 is the FDA 510(k) clearance for SCX INFORMATION MANAGEMENT SYSTEM by General Electric Co.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K870400 · General Electric Co. · Radiology device
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Jun 1987
Decision
136d
Days
Class 2
Risk

K870400 is an FDA 510(k) clearance for the SCX INFORMATION MANAGEMENT SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on June 18, 1987 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 K870400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1987
Decision Date June 18, 1987
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K870400.
MTX GENERATOR
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DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
K853753 · Victoreen, Inc. · Oct 1985
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K813173 · General Electric Co. · Dec 1981
DSS 500
K811934 · Philips Medical Systems (Cleveland), Inc. · Aug 1981