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FDA 510(k)

VALORY

K-Number: K213469 · 2021-11-18

ApplicantAgfa N.V.
Decision Date2021-11-18
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VALORY is a medical device manufactured by Agfa N.V.. It received FDA 510(k) clearance on 2021-11-18 under approval number K213469. 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 VALORY?

VALORY is a medical device that received FDA 510(k) clearance on 2021-11-18. It is manufactured by Agfa N.V.. The 510(k) number is K213469.

When was VALORY approved by the FDA?

VALORY received FDA 510(k) clearance on 2021-11-18, under approval number K213469.

What company makes VALORY?

VALORY is manufactured by Agfa N.V..

What is the FDA product code for VALORY?

The FDA product code for VALORY is MQB.

Other Devices by Agfa N.V.

K191884DR 100s K183275DR 800 with Tomosynthesis K193262DR 600 with Tomosynthesis K212145DR 800 with DSA, DR 800 K211790DX-D Imaging Package with XD Detectors

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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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