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FDA 510(k)

DRX-Revolution Mobile X-ray System

K-Number: K191025 · 2019-05-17

ApplicantCarestream Health, Inc.
Decision Date2019-05-17
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX-Revolution Mobile X-ray System is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-05-17 under approval number K191025. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRX-Revolution Mobile X-ray System?

DRX-Revolution Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2019-05-17. It is manufactured by Carestream Health, Inc.. The 510(k) number is K191025.

When was DRX-Revolution Mobile X-ray System approved by the FDA?

DRX-Revolution Mobile X-ray System received FDA 510(k) clearance on 2019-05-17, under approval number K191025.

What company makes DRX-Revolution Mobile X-ray System?

DRX-Revolution Mobile X-ray System is manufactured by Carestream Health, Inc..

What is the FDA product code for DRX-Revolution Mobile X-ray System?

The FDA product code for DRX-Revolution Mobile X-ray System is IZL.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Carestream Health, Inc.

K163203Carestream DRX-Evolution K160723OnSight 3D Extremity System K153103CARESTREAM Vue PACS K170755DRX-Revolution Nano Mobile X-ray System K170580Carestream Vue PACS K180809Eclipse II

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Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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