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FDA 510(k)

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

K-Number: K253185 · 2026-03-11

ApplicantCarestream Health
Decision Date2026-03-11
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is a medical device manufactured by Carestream Health. It received FDA 510(k) clearance on 2026-03-11 under approval number K253185. 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 Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is a medical device that received FDA 510(k) clearance on 2026-03-11. It is manufactured by Carestream Health. The 510(k) number is K253185.

When was Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System approved by the FDA?

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System received FDA 510(k) clearance on 2026-03-11, under approval number K253185.

What company makes Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is manufactured by Carestream Health.

What is the FDA product code for Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System?

The FDA product code for Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is IZL.

Related Clinical Trials

NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT07541365 Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials NOT_YET_RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING NCT07572318 Pilot Study on the Feasibility of High-energy Collimation With Optimized Geometry on a VERITON™ CZT Camera NOT_YET_RECRUITING

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 K213568DRX-Rise 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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