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FDA 510(k)

IMPAX NEXT GENERATION

K-Number: K111945 · 2011-08-05

ApplicantAgfa Healthcare N.V.
Decision Date2011-08-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPAX NEXT GENERATION 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 2011-08-05 under 510(k) number K111945. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPAX NEXT GENERATION?

IMPAX NEXT GENERATION is a medical device that received FDA 510(k) clearance on 2011-08-05. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K111945.

When did IMPAX NEXT GENERATION receive FDA 510(k) clearance?

IMPAX NEXT GENERATION received FDA 510(k) clearance on 2011-08-05, under 510(k) number K111945.

Who is the listed applicant for IMPAX NEXT GENERATION?

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 IMPAX NEXT GENERATION?

The FDA product code for IMPAX NEXT GENERATION is LLZ.

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Other records listing Agfa Healthcare N.V. 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.

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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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