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 a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-03-17 under approval 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. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K250379.
When was SIGNA Prime Elite approved by the FDA?
SIGNA Prime Elite received FDA 510(k) clearance on 2025-03-17, under approval number K250379.
What company makes SIGNA Prime Elite?
SIGNA Prime Elite is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for SIGNA Prime Elite?
The FDA product code for SIGNA Prime Elite is LNH.
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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.