Search Results
Found 2 results
510(k) Data Aggregation
K Number
K241505Device Name
DRX-Revolution Mobile X-ray System
Manufacturer
Carestream Health Inc.
Date Cleared
2024-12-10
(196 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Carestream Health Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.
Device Description
The DRX-Revolution Mobile X-ray System is a mobile diagnostic x-ray system that utilizes digital technology for bedside or portable exams. Key components of the system are the x-ray generator, a tube head assembly (includes the x-ray tube and collimator) that allows for multiple axes of movement, a maneuverable drive system, touchscreen user interface(s) for user input. The system is designed with installable software for acquiring and processing medical diagnostic images outside of a standard stationary X-ray room. It is a mobile diagnostic system intended to generate and control X-rays for examination of various anatomical regions.
Ask a Question
K Number
K191025Device Name
DRX-Revolution Mobile X-ray System
Manufacturer
Carestream Health Inc.
Date Cleared
2019-05-17
(29 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Carestream Health Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is designed to perform radiographic x-ray examinations on all pediatric and adult patient treatment areas.
Device Description
The DRX-Revolution Mobile X-ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. The system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of a standard stationary xray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.
Ask a Question
Page 1 of 1