Cleared Traditional

K936136 - UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE

K936136 is an FDA 510(k) clearance for UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE, 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 34-day FDA review.

K936136 · Ge Dec Medical Systems · Radiology device
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Jan 1994
Decision
34d
Days
Class 2
Risk

K936136 is an FDA 510(k) clearance for the UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE. 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 January 25, 1994 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ge Dec Medical Systems devices

FDA 510(k) Submission Details - K936136

510(k) Number K936136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1993
Decision Date January 25, 1994
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
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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