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FDA 510(k)

Omni Legend

K-Number: K241665 · 2024-08-08

ApplicantGe Medical Systems Israel, Functional Imaging
Decision Date2024-08-08
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Omni Legend is a medical device manufactured by Ge Medical Systems Israel, Functional Imaging. It received FDA 510(k) clearance on 2024-08-08 under approval number K241665. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omni Legend?

Omni Legend is a medical device that received FDA 510(k) clearance on 2024-08-08. It is manufactured by Ge Medical Systems Israel, Functional Imaging. The 510(k) number is K241665.

When was Omni Legend approved by the FDA?

Omni Legend received FDA 510(k) clearance on 2024-08-08, under approval number K241665.

What company makes Omni Legend?

Omni Legend is manufactured by Ge Medical Systems Israel, Functional Imaging.

What is the FDA product code for Omni Legend?

The FDA product code for Omni Legend is KPS.

Other Devices by Ge Medical Systems Israel, Functional Imaging

K243605Aurora K241350Clarify DL

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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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