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FDA 510(k)

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS

K-Number: K092238 · 2009-08-11

ApplicantAgfa Healthcare N.V.
Decision Date2009-08-11
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS 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 2009-08-11 under 510(k) number K092238. 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 DX-G DIGITIZERS?

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS is a medical device that received FDA 510(k) clearance on 2009-08-11. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K092238.

When did AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS receive FDA 510(k) clearance?

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS received FDA 510(k) clearance on 2009-08-11, under 510(k) number K092238.

Who is the listed applicant for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS?

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 DX-G DIGITIZERS?

The FDA product code for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS is MQB.

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Other records listing Agfa Healthcare N.V. as applicant

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Related Devices (Code: MQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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