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FDA 510(k)

DRX-Revolution Nano Mobile X-ray System

K-Number: K170755 · 2017-06-21

ApplicantCarestream Health, Inc.
Decision Date2017-06-21
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRX-Revolution Nano Mobile X-ray System is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2017-06-21 under approval number K170755. 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 Nano Mobile X-ray System?

DRX-Revolution Nano Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Carestream Health, Inc.. The 510(k) number is K170755.

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

DRX-Revolution Nano Mobile X-ray System received FDA 510(k) clearance on 2017-06-21, under approval number K170755.

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

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

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

The FDA product code for DRX-Revolution Nano 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.

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Related Devices (Code: IZL)

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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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