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FDA 510(k)

CARESTREAM DRX-1 SYSTEM

K-Number: K090318 · 2009-04-06

ApplicantCarestream Health, Inc.
Decision Date2009-04-06
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARESTREAM DRX-1 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 2009-04-06 under 510(k) number K090318. 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?

CARESTREAM DRX-1 SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-06. The listed applicant is Carestream Health, Inc.. The 510(k) number is K090318.

When did CARESTREAM DRX-1 SYSTEM receive FDA 510(k) clearance?

CARESTREAM DRX-1 SYSTEM received FDA 510(k) clearance on 2009-04-06, under 510(k) number K090318.

Who is the listed applicant for CARESTREAM DRX-1 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 CARESTREAM DRX-1 SYSTEM?

The FDA product code for CARESTREAM DRX-1 SYSTEM is MQB.

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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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