Cleared Special

K201373 - DRX-Compass

K201373 is the FDA 510(k) clearance for DRX-Compass by Carestream Health, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Special 510(k) pathway after a 31-day FDA review.

K201373 · Carestream Health, Inc. · Radiology device
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Jun 2020
Decision
31d
Days
Class 2
Risk

K201373 is an FDA 510(k) clearance for the DRX-Compass. 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 June 26, 2020 after a review of 31 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 Carestream Health, Inc. devices

Submission Details

510(k) Number K201373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2020
Decision Date June 26, 2020
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 164
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