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FDA 510(k)

DRX-Revolution Mobile X-ray System

K-Number: K241505 · 2024-12-10

ApplicantCarestream Health, Inc.
Decision Date2024-12-10
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX-Revolution Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2024-12-10 under 510(k) number K241505. 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 2024-12-10. The listed applicant is Carestream Health, Inc.. The 510(k) number is K241505.

When did DRX-Revolution Mobile X-ray System receive FDA 510(k) clearance?

DRX-Revolution Mobile X-ray System received FDA 510(k) clearance on 2024-12-10, under 510(k) number K241505.

Who is the listed applicant for DRX-Revolution Mobile X-ray System?

The FDA 510(k) record lists Carestream Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Carestream Health, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemK250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorK251168Image SuiteK233381DRX-Evolution Plus SystemK223842DRX - CompassK213568DRX-Rise Mobile X-ray System

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Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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