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FDA 510(k)

SIGNA Prime Elite

K-Number: K250379 · 2025-03-17

ApplicantGe Medical Systems, LLC
Decision Date2025-03-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA Prime Elite is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-03-17 under 510(k) number K250379. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNA Prime Elite?

SIGNA Prime Elite is a medical device that received FDA 510(k) clearance on 2025-03-17. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K250379.

When did SIGNA Prime Elite receive FDA 510(k) clearance?

SIGNA Prime Elite received FDA 510(k) clearance on 2025-03-17, under 510(k) number K250379.

Who is the listed applicant for SIGNA Prime Elite?

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

What is the FDA product code for SIGNA Prime Elite?

The FDA product code for SIGNA Prime Elite is LNH.

Other records listing Ge Medical Systems, LLC 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: LNH)

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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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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