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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 a medical device manufactured by Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2016-06-22 under approval 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. It is manufactured by Agfa Healthcare N.V.. The 510(k) number is K161061.

When was IMPAX Volume Viewing 4.0 approved by the FDA?

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

What company makes IMPAX Volume Viewing 4.0?

IMPAX Volume Viewing 4.0 is manufactured by Agfa Healthcare N.V..

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 Devices by Agfa Healthcare N.V.

K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) K172784DX-D Imaging Package K170434Enterprise Imaging XERO Viewer 8.1 K180589DR 800 with MUSICA Dynamic K252199AGFA HealthCare Enterprise Imaging

Related Devices (Code: LLZ)

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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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