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FDA 510(k)

Ortho AI

K-Number: K241696 · 2025-01-02

ApplicantOrtho Ai, LLC
Decision Date2025-01-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ortho AI is a medical device manufactured by Ortho Ai, LLC. It received FDA 510(k) clearance on 2025-01-02 under approval number K241696. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ortho AI?

Ortho AI is a medical device that received FDA 510(k) clearance on 2025-01-02. It is manufactured by Ortho Ai, LLC. The 510(k) number is K241696.

When was Ortho AI approved by the FDA?

Ortho AI received FDA 510(k) clearance on 2025-01-02, under approval number K241696.

What company makes Ortho AI?

Ortho AI is manufactured by Ortho Ai, LLC.

What is the FDA product code for Ortho AI?

The FDA product code for Ortho AI is QIH.

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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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