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FDA 510(k)

DRX-Rise Mobile X-ray System

K-Number: K213568 · 2022-03-23

ApplicantCarestream Health
Decision Date2022-03-23
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX-Rise Mobile X-ray System is a medical device manufactured by Carestream Health. It received FDA 510(k) clearance on 2022-03-23 under approval number K213568. 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-Rise Mobile X-ray System?

DRX-Rise Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Carestream Health. The 510(k) number is K213568.

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

DRX-Rise Mobile X-ray System received FDA 510(k) clearance on 2022-03-23, under approval number K213568.

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

DRX-Rise Mobile X-ray System is manufactured by Carestream Health.

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

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

Related Clinical Trials

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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

K163157SmartGrid K203159Lux 35 Detector K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector

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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