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FDA 510(k)

AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS

K-Number: K071162 · 2007-05-08

ApplicantAgfa Healthcare Corp.
Decision Date2007-05-08
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare Corp.. It received FDA 510(k) clearance on 2007-05-08 under 510(k) number K071162. 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 SYSTEM WITH NX2.X WORKSTATIONS?

AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS is a medical device that received FDA 510(k) clearance on 2007-05-08. The listed applicant is Agfa Healthcare Corp.. The 510(k) number is K071162.

When did AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS receive FDA 510(k) clearance?

AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS received FDA 510(k) clearance on 2007-05-08, under 510(k) number K071162.

Who is the listed applicant for AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS?

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

What is the FDA product code for AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS?

The FDA product code for AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS is MQB.

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Other records listing Agfa Healthcare Corp. 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.

K071972ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONSK071297IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)

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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