SIGNA Sprint
K-Number: K251399 · 2025-09-11
ApplicantGe Medical Systems, LLC
Decision Date2025-09-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Sprint is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-09-11 under approval number K251399. 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 Sprint?
SIGNA Sprint is a medical device that received FDA 510(k) clearance on 2025-09-11. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K251399.
When was SIGNA Sprint approved by the FDA?
SIGNA Sprint received FDA 510(k) clearance on 2025-09-11, under approval number K251399.
What company makes SIGNA Sprint?
SIGNA Sprint is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for SIGNA Sprint?
The FDA product code for SIGNA Sprint 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.