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DRX-Evolution

by Carestream Health, Inc.

510(k) K141837

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK141837 Date11 Mar 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2449-2015 FDA Class II initiated 7 Aug 2015

    Software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.

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  • Withdrawn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, 1 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 is a stationary X-ray imaging system designed for radiology applications. It provides digital radiography capabilities, enabling high-quality image acquisition and processing for diagnostic purposes. The system is engineered to support a range of clinical studies, including orthopaedic and long-length imaging, with modular flexibility to adapt to varying workflows and spatial requirements.

The DRX-Evolution is supplied as a reusable, stationary X-ray system intended for use in radiology departments. It operates in non-MRI environments and is classified as a Class II medical device under FDA regulations. The system is authorized via a 510(k) clearance (K141837) and is intended for integration into existing or future imaging workflows, with no indication of single-use or sterility requirements. Storage and maintenance are manufacturer-specific, adhering to FDA regulation 892.1680.

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Questions

AI-generated answers, 1 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 clinical applications is the DRX-Evolution designed for?

    The DRX-Evolution is engineered for digital radiography in radiology departments, specifically supporting orthopaedic studies and long-length imaging. Its modular design allows flexibility to adapt to various workflows and spatial requirements, ensuring versatility in clinical settings.

  • Is the DRX-Evolution intended for single-use or reusable applications?

    The DRX-Evolution is supplied as a reusable, stationary X-ray system. It is not designed for single-use, and there are no sterility requirements specified for its operation.

  • What regulatory pathway does the DRX-Evolution follow?

    The DRX-Evolution is classified as a Class II medical device under FDA regulations and has received a 510(k) clearance (K141837). It is authorized for use in non-MRI environments and adheres to FDA regulation 892.1680 for storage and maintenance.

  • Can the DRX-Evolution be integrated into existing imaging workflows?

    Yes, the DRX-Evolution is explicitly designed for integration into existing or future imaging workflows. Its modular flexibility ensures compatibility with various departmental setups, enhancing adaptability in radiology environments.

  • What type of maintenance and storage guidelines apply to the DRX-Evolution?

    Maintenance and storage guidelines for the DRX-Evolution are manufacturer-specific, as outlined in FDA regulation 892.1680. Users should follow Carestream Health’s instructions to ensure proper operation, longevity, and compliance with regulatory standards.