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FDA 510(k)

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS

K-Number: K090672 · 2009-05-18

ApplicantAgfa Healthcare N.V.
Decision Date2009-05-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS 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 2009-05-18 under 510(k) number K090672. 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 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS?

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS is a medical device that received FDA 510(k) clearance on 2009-05-18. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K090672.

When did AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS receive FDA 510(k) clearance?

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS received FDA 510(k) clearance on 2009-05-18, under 510(k) number K090672.

Who is the listed applicant for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS?

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 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS?

The FDA product code for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS is 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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