Cleared Traditional

K191879 - DRX-Evolution with Carestream Digital Tomosynthesis

K191879 is an FDA 510(k) clearance for DRX-Evolution with Carestream Digital T..., manufactured by Carestream Health, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K191879

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.

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 262
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K191879.
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Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
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EOSedge
K192079 · Eos Imaging · Nov 2019
DRX-Evolution/Plus with Dual Energy
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DigiX FDX
K192541 · Allengers Medical Systems Limited · Oct 2019