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FDA 510(k)

Saige-Dx

K-Number: K251873 · 2025-08-11

ApplicantDeepHealth, Inc.
Decision Date2025-08-11
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Saige-Dx is a medical device manufactured by DeepHealth, Inc.. It received FDA 510(k) clearance on 2025-08-11 under approval 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. It is manufactured by DeepHealth, Inc.. The 510(k) number is K251873.

When was Saige-Dx approved by the FDA?

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

What company makes Saige-Dx?

Saige-Dx is manufactured by DeepHealth, Inc..

What is the FDA product code for Saige-Dx?

The FDA product code for Saige-Dx is QDQ.

Other Devices by DeepHealth, Inc.

K203517Saige-Q K222275Saige-Density K220105Saige-Dx 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.

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