Cleared Special

K031874 - MODIFICATION TO WBR, MODEL HR

K031874 is an FDA 510(k) clearance for MODIFICATION TO WBR, manufactured by U.C.G. Technologies , Ltd.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 31-day FDA review.

K031874 · U.C.G. Technologies , Ltd. · Radiology device
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Jul 2003
Decision
31d
Days
Class 2
Risk

K031874 is an FDA 510(k) clearance for the MODIFICATION TO WBR, MODEL HR. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by U.C.G. Technologies , Ltd. (Haifa, IL). The FDA issued a Cleared decision on July 18, 2003 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all U.C.G. Technologies , Ltd. devices

FDA 510(k) Submission Details - K031874

510(k) Number K031874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2003
Decision Date July 18, 2003
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 348
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