FDA 510(k)

ScreenDx

K-Number: K241891 · 2025-01-10

Decision Date2025-01-10

Product CodeQWO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ScreenDx is the device name listed in this FDA 510(k) record. The listed applicant is Imvaria, Inc.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) 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. The listed applicant is Imvaria, Inc.. The 510(k) number is K241891.

When did ScreenDx receive FDA 510(k) clearance?

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

Who is the listed applicant for ScreenDx?

The FDA 510(k) record lists Imvaria, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ScreenDx?

The FDA product code for ScreenDx is QWO.

Other records listing Imvaria, Inc. 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.

K252041Fibresolve (with PCCP)

Related Devices (Code: QWO)

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