Cleared Special

K193574 - Q-Rad System

K193574 is an FDA 510(k) clearance for Q-Rad System, manufactured by Carestream Health, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 30-day FDA review.

K193574 · Carestream Health, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
30d
Days
Class 2
Risk

K193574 is an FDA 510(k) clearance for the Q-Rad System. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Carestream Health, Inc. (China (Shanghai) Pilot Free Trade Zone, CN). The FDA issued a Cleared decision on January 22, 2020 after a review of 30 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.

FDA 510(k) Submission Details - K193574

510(k) Number K193574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date January 22, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
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 357
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K193574.
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K193360 · Radmedix, LLC · Jan 2020
DRX-Evolution with Carestream Digital Tomosynthesis
K191879 · Carestream Health, Inc. · Dec 2019
K193574 · Q-Rad System
Download PDF FDA Summary Carestream Health, In…