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 the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Israel, Functional Imaging. It received FDA 510(k) clearance on 2024-08-08 under 510(k) 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. The listed applicant is Ge Medical Systems Israel, Functional Imaging. The 510(k) number is K241665.

When did Omni Legend receive FDA 510(k) clearance?

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

Who is the listed applicant for Omni Legend?

The FDA 510(k) record lists Ge Medical Systems Israel, Functional Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omni Legend?

The FDA product code for Omni Legend is KPS.

Other records listing Ge Medical Systems Israel, Functional Imaging 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.

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Related Devices (Code: KPS)

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.