Cleared Traditional

K072191 - CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM

K072191 is an FDA 510(k) clearance for CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM, manufactured by Gvi Technology Partners. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K072191 · Gvi Technology Partners · Radiology device
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Oct 2007
Decision
80d
Days
Class 2
Risk

K072191 is an FDA 510(k) clearance for the CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Gvi Technology Partners (Twinsburg, US). The FDA issued a Cleared decision on October 25, 2007 after a review of 80 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. 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 Gvi Technology Partners devices

FDA 510(k) Submission Details - K072191

510(k) Number K072191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date October 25, 2007
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 326
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K072191.
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K070542 · Digirad Corp. · Mar 2007
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K062393 · Ge Healthcare · Sep 2006