Cleared Special

K151924 - Q-Rad Radiographic System with Auto-Tra...

K151924 is an FDA 510(k) clearance for Q-Rad Radiographic System with Auto-Tra..., manufactured by Quantum Medical Imaging Divison of Carestream. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 25-day FDA review.

K151924 · Quantum Medical Imaging Divison of Carestream · Radiology device
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Aug 2015
Decision
25d
Days
Class 2
Risk

K151924 is an FDA 510(k) clearance for the Q-Rad Radiographic System with Auto-Tracker Option. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Quantum Medical Imaging Divison of Carestream (Ronkonkoma, US). The FDA issued a Cleared decision on August 7, 2015 after a review of 25 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 Divison of Carestream devices

FDA 510(k) Submission Details - K151924

510(k) Number K151924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2015
Decision Date August 07, 2015
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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.

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