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FDA 510(k)

Carestream DRX-1 System with DRX Plus 2530 Detectors

K-Number: K183245 · 2019-02-08

ApplicantCarestream Health, Inc.
Decision Date2019-02-08
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Carestream DRX-1 System with DRX Plus 2530 Detectors is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-02-08 under approval number K183245. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carestream DRX-1 System with DRX Plus 2530 Detectors?

Carestream DRX-1 System with DRX Plus 2530 Detectors is a medical device that received FDA 510(k) clearance on 2019-02-08. It is manufactured by Carestream Health, Inc.. The 510(k) number is K183245.

When was Carestream DRX-1 System with DRX Plus 2530 Detectors approved by the FDA?

Carestream DRX-1 System with DRX Plus 2530 Detectors received FDA 510(k) clearance on 2019-02-08, under approval number K183245.

What company makes Carestream DRX-1 System with DRX Plus 2530 Detectors?

Carestream DRX-1 System with DRX Plus 2530 Detectors is manufactured by Carestream Health, Inc..

What is the FDA product code for Carestream DRX-1 System with DRX Plus 2530 Detectors?

The FDA product code for Carestream DRX-1 System with DRX Plus 2530 Detectors is MQB.

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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: MQB)

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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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