SIGNA Prime
K-Number: K211980 · 2022-01-16
Decision Date2022-01-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Prime is a medical device manufactured by Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2022-01-16 under approval number K211980. 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?
SIGNA Prime is a medical device that received FDA 510(k) clearance on 2022-01-16. It is manufactured by Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K211980.
When was SIGNA Prime approved by the FDA?
SIGNA Prime received FDA 510(k) clearance on 2022-01-16, under approval number K211980.
What company makes SIGNA Prime?
SIGNA Prime is manufactured by Ge Healthcare (Tianjin) Company Limited.
What is the FDA product code for SIGNA Prime?
The FDA product code for SIGNA Prime 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.