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FDA 510(k)

Carestream DRX-1 System with DRX Core Detectors

K-Number: K183474 · 2019-01-16

ApplicantCarestream Health, Inc.
Decision Date2019-01-16
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Carestream DRX-1 System with DRX Core Detectors is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2019-01-16 under approval number K183474. 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 Core Detectors?

Carestream DRX-1 System with DRX Core Detectors is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Carestream Health, Inc.. The 510(k) number is K183474.

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

Carestream DRX-1 System with DRX Core Detectors received FDA 510(k) clearance on 2019-01-16, under approval number K183474.

What company makes Carestream DRX-1 System with DRX Core Detectors?

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

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

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

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Other Devices by Carestream Health, Inc.

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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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