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FDA 510(k)

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS

K-Number: K081963 · 2008-07-25

ApplicantAgfa Healthcare Corporation
Decision Date2008-07-25
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare Corporation. It received FDA 510(k) clearance on 2008-07-25 under 510(k) number K081963. 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 NX2008 WORKSTATIONS?

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS is a medical device that received FDA 510(k) clearance on 2008-07-25. The listed applicant is Agfa Healthcare Corporation. The 510(k) number is K081963.

When did AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS receive FDA 510(k) clearance?

AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS received FDA 510(k) clearance on 2008-07-25, under 510(k) number K081963.

Who is the listed applicant for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS?

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

What is the FDA product code for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS?

The FDA product code for AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS is MQB.

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Other records listing Agfa Healthcare Corporation as applicant

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.

K081976IMPAX MA3000 DIAGNOSTIC PACS WORKSTATIONK080013REGISTRATION AND FUSIONK073271ORTHOGONK072680DRYSTAR AXYS, MODEL EYZ4E

Related Devices (Code: MQB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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