Signa Voyager, Signa Voyager Quantum
K-Number: K192426 · 2019-10-01
Decision Date2019-10-01
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Signa Voyager, Signa Voyager Quantum is a medical device manufactured by Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2019-10-01 under approval number K192426. 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 Voyager, Signa Voyager Quantum?
Signa Voyager, Signa Voyager Quantum is a medical device that received FDA 510(k) clearance on 2019-10-01. It is manufactured by Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K192426.
When was Signa Voyager, Signa Voyager Quantum approved by the FDA?
Signa Voyager, Signa Voyager Quantum received FDA 510(k) clearance on 2019-10-01, under approval number K192426.
What company makes Signa Voyager, Signa Voyager Quantum?
Signa Voyager, Signa Voyager Quantum is manufactured by Ge Healthcare (Tianjin) Company Limited.
What is the FDA product code for Signa Voyager, Signa Voyager Quantum?
The FDA product code for Signa Voyager, Signa Voyager Quantum 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.