Cleared Traditional

K191879 - DRX-Evolution with Carestream Digital T...

K191879 is the FDA 510(k) clearance for DRX-Evolution with Carestream Digital T... by Carestream Health, Inc.. It is a Class 2 Radiology device (product code KPR) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K191879 · Carestream Health, Inc. · Radiology device
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Dec 2019
Decision
158d
Days
Class 2
Risk

K191879 is an FDA 510(k) clearance for the DRX-Evolution with Carestream Digital Tomosynthesis. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on December 20, 2019 after a review of 158 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carestream Health, Inc. devices

Submission Details

510(k) Number K191879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2019
Decision Date December 20, 2019
Days to Decision 158 days
Submission Type Traditional
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
51d slower than avg
Panel avg: 107d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K191879.
Q-Rad System
K193574 · Carestream Health, Inc. · Jan 2020
KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography
K193225 · Konica Minolta Healthcare Americas, Inc. · Jan 2020
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
K193360 · Radmedix, LLC · Jan 2020
EOSedge
K192079 · Eos Imaging · Nov 2019
DRX-Evolution/Plus with Dual Energy
K190330 · Carestream Health, Inc. · Nov 2019
DigiX FDX
K192541 · Allengers Medical Systems Limited · Oct 2019