Cleared Traditional

K940295 - UROVIEW MODEL 2600

K940295 is an FDA 510(k) clearance for UROVIEW MODEL 2600, manufactured by Ge Dec Medical Systems. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K940295 · Ge Dec Medical Systems · Radiology device
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Aug 1994
Decision
213d
Days
Class 2
Risk

K940295 is an FDA 510(k) clearance for the UROVIEW MODEL 2600. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Ge Dec Medical Systems (Salt Lake City, US). The FDA issued a Cleared decision on August 22, 1994 after a review of 213 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Ge Dec Medical Systems devices

FDA 510(k) Submission Details - K940295

510(k) Number K940295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1994
Decision Date August 22, 1994
Days to Decision 213 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 107d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 164
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