Magnifico Open, Magnifico MSK
K-Number: K212419 · 2022-02-04
ApplicantEsaote, S.p.A.
Decision Date2022-02-04
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Magnifico Open, Magnifico MSK is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2022-02-04 under approval number K212419. 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 Magnifico Open, Magnifico MSK?
Magnifico Open, Magnifico MSK is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Esaote, S.p.A.. The 510(k) number is K212419.
When was Magnifico Open, Magnifico MSK approved by the FDA?
Magnifico Open, Magnifico MSK received FDA 510(k) clearance on 2022-02-04, under approval number K212419.
What company makes Magnifico Open, Magnifico MSK?
Magnifico Open, Magnifico MSK is manufactured by Esaote, S.p.A..
What is the FDA product code for Magnifico Open, Magnifico MSK?
The FDA product code for Magnifico Open, Magnifico MSK is LNH.
Other Devices by Esaote, S.p.A.
Related Devices (Code: LNH)
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.
K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.
K162403HyperBandGe Medical Systems, LLC
K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
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.