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FDA 510(k)

CR 12-X DIGITIZER

K-Number: K131408 · 2013-08-29

ApplicantAgfa Healthcare N.V.
Decision Date2013-08-29
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CR 12-X DIGITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2013-08-29 under 510(k) number K131408. 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 CR 12-X DIGITIZER?

CR 12-X DIGITIZER is a medical device that received FDA 510(k) clearance on 2013-08-29. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K131408.

When did CR 12-X DIGITIZER receive FDA 510(k) clearance?

CR 12-X DIGITIZER received FDA 510(k) clearance on 2013-08-29, under 510(k) number K131408.

Who is the listed applicant for CR 12-X DIGITIZER?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CR 12-X DIGITIZER?

The FDA product code for CR 12-X DIGITIZER is MQB.

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Other records listing Agfa Healthcare N.V. as applicant

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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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