Cleared Traditional

K190330 - DRX-Evolution/Plus with Dual Energy (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190330 · Carestream Health, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
263d
Days
Class 2
Risk

K190330 is an FDA 510(k) clearance for the DRX-Evolution/Plus with Dual Energy. 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 November 4, 2019 after a review of 263 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 K190330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2019
Decision Date November 04, 2019
Days to Decision 263 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 107d · This submission: 263d
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 354
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K190330.
AeroDR TX c02
K253446 · Dk Medical Systems Co., Ltd. · Apr 2026
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
K250954 · Carestream Health · Jan 2026
uDR Arria & uDR Aris
K252000 · Shanghai United Imaging Healthcare Co., Ltd. · Nov 2025
uDR Aurora CX
K251167 · Shanghai United Imaging Healthcare Co., Ltd. · Sep 2025
Definium Tempo Select
K250788 · Ge Hualun Medical Systems Co. , Ltd. · Aug 2025
INNOVISION-DXII
K250790 · Dk Medical Systems Co., Ltd. · Aug 2025