FDA 510(k)

Saige-Dx

K-Number: K251873 · 2025-08-11

Decision Date2025-08-11

Product CodeQDQ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Saige-Dx is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K251873. 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?

Saige-Dx is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is DeepHealth, Inc.. The 510(k) number is K251873.

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

Saige-Dx received FDA 510(k) clearance on 2025-08-11, under 510(k) number K251873.

Who is the listed applicant for Saige-Dx?

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?

The FDA product code for Saige-Dx 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 K243703TechLive K243705Saige-Density (2.5.0)K243688Saige-Dx (3.1.0)K241747Saige-Dx

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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.