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FDA 510(k)

Omni Legend

K-Number: K221932 · 2022-09-02

ApplicantGE Healthcare
Decision Date2022-09-02
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 Healthcare. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K221932. 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 2022-09-02. The listed applicant is GE Healthcare. The 510(k) number is K221932.

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

Omni Legend received FDA 510(k) clearance on 2022-09-02, under 510(k) number K221932.

Who is the listed applicant for Omni Legend?

The FDA 510(k) record lists GE Healthcare 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.

Related Clinical Trials

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.

Other records listing GE Healthcare 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)

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.

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.