SIGNA Architect
K-Number: K202966 · 2020-11-13
Decision Date2020-11-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Architect is a medical device manufactured by Ge Healthcare (Ge Medical Systems, LLC). It received FDA 510(k) clearance on 2020-11-13 under approval number K202966. 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 Architect?
SIGNA Architect is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Ge Healthcare (Ge Medical Systems, LLC). The 510(k) number is K202966.
When was SIGNA Architect approved by the FDA?
SIGNA Architect received FDA 510(k) clearance on 2020-11-13, under approval number K202966.
What company makes SIGNA Architect?
SIGNA Architect is manufactured by Ge Healthcare (Ge Medical Systems, LLC).
What is the FDA product code for SIGNA Architect?
The FDA product code for SIGNA Architect 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.