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FDA 510(k)

IMPAX Volume Viewing 4.0

K-Number: K161061 · 2016-06-22

ApplicantAgfa Healthcare N.V.
Decision Date2016-06-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPAX Volume Viewing 4.0 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 2016-06-22 under 510(k) number K161061. 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 Volume Viewing 4.0?

IMPAX Volume Viewing 4.0 is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K161061.

When did IMPAX Volume Viewing 4.0 receive FDA 510(k) clearance?

IMPAX Volume Viewing 4.0 received FDA 510(k) clearance on 2016-06-22, under 510(k) number K161061.

Who is the listed applicant for IMPAX Volume Viewing 4.0?

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 Volume Viewing 4.0?

The FDA product code for IMPAX Volume Viewing 4.0 is LLZ.

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.

K252199AGFA HealthCare Enterprise ImagingK180589DR 800 with MUSICA DynamicK172784DX-D Imaging PackageK170434Enterprise Imaging XERO Viewer 8.1K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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