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DRX-Evolution Plus System

by Carestream Health, Inc.

510(k) K233381

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233381 Date12 Mar 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KPR
Device class
Class II
Regulation
21 CFR Part 892.1680
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DRX-Evolution Plus System is a stationary X-ray system designed for radiology imaging. It is a digital X-ray room system that provides imaging functions including generator operation, digital-image acquisition, and processing from a single console.

The system is supplied as a modular X-ray room solution for use in healthcare facilities. It is authorized under FDA 510(k) clearance (K233381) and is intended for general radiology applications.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DRX-Evolution Plus System used for?

    The DRX-Evolution Plus System is designed for radiology imaging and provides imaging functions including generator operation, digital-image acquisition, and processing from a single console for general radiology applications in healthcare facilities.

  • How is the DRX-Evolution Plus System supplied and configured?

    The system is supplied as a modular X-ray room solution, meaning it is delivered in components that can be assembled and installed as a stationary digital X-ray room system for use in healthcare facilities.

  • What regulatory authorization does the DRX-Evolution Plus System have?

    The DRX-Evolution Plus System is authorized under FDA 510(k) clearance (K233381) and is classified as a Class II medical device under product code KPR for stationary X-ray systems.