Cleared Special

K083181 - QV-9000 UNIVERSAL SYSTEM

K083181 is an FDA 510(k) clearance for QV-9000 UNIVERSAL SYSTEM, manufactured by Quantum Medical Imaging, LLC. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 29-day FDA review.

K083181 · Quantum Medical Imaging, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
29d
Days
Class 2
Risk

K083181 is an FDA 510(k) clearance for the QV-9000 UNIVERSAL SYSTEM. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Quantum Medical Imaging, LLC (Ronkonkoma, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Quantum Medical Imaging, LLC devices

FDA 510(k) Submission Details - K083181

510(k) Number K083181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2008
Decision Date November 26, 2008
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

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 222
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K083181.
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YSIO
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K080553 · Vieworks Co., Ltd. · Apr 2008