FDA 510(k)

Saige-Dx (3.1.0)

K-Number: K243688 · 2024-12-19

Decision Date2024-12-19

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Saige-Dx (3.1.0) is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243688. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Saige-Dx (3.1.0)?

Saige-Dx (3.1.0) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is DeepHealth, Inc.. The 510(k) number is K243688.

When did Saige-Dx (3.1.0) receive FDA 510(k) clearance?

Saige-Dx (3.1.0) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243688.

Who is the listed applicant for Saige-Dx (3.1.0)?

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

What is the FDA product code for Saige-Dx (3.1.0)?

The FDA product code for Saige-Dx (3.1.0) is QDQ.

Other records listing DeepHealth, 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.

K253825Saige-Dx K254131BAC K251873Saige-Dx K243703TechLive K243705Saige-Density (2.5.0)K241747Saige-Dx

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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.