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FDA 510(k)

ScreenDx

K-Number: K241891 · 2025-01-10

ApplicantImvaria, Inc.
Decision Date2025-01-10
Product CodeQWO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ScreenDx is a medical device manufactured by Imvaria, Inc.. It received FDA 510(k) clearance on 2025-01-10 under approval number K241891. The device is classified under product code QWO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ScreenDx?

ScreenDx is a medical device that received FDA 510(k) clearance on 2025-01-10. It is manufactured by Imvaria, Inc.. The 510(k) number is K241891.

When was ScreenDx approved by the FDA?

ScreenDx received FDA 510(k) clearance on 2025-01-10, under approval number K241891.

What company makes ScreenDx?

ScreenDx is manufactured by Imvaria, Inc..

What is the FDA product code for ScreenDx?

The FDA product code for ScreenDx is QWO.

Other Devices by Imvaria, Inc.

DEN220040Fibresolve K252041Fibresolve (with PCCP)

Related Devices (Code: QWO)

K242467IQ-UIPImbio, Inc. DEN220040FibresolveImvaria, Inc. K252041Fibresolve (with PCCP)Imvaria, Inc.

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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