ECHELON Oval V6.2 MRI System
K-Number: K221619 · 2023-01-26
ApplicantFujifilm Healthcare Corporation
Decision Date2023-01-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ECHELON Oval V6.2 MRI System is a medical device manufactured by Fujifilm Healthcare Corporation. It received FDA 510(k) clearance on 2023-01-26 under approval number K221619. 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 ECHELON Oval V6.2 MRI System?
ECHELON Oval V6.2 MRI System is a medical device that received FDA 510(k) clearance on 2023-01-26. It is manufactured by Fujifilm Healthcare Corporation. The 510(k) number is K221619.
When was ECHELON Oval V6.2 MRI System approved by the FDA?
ECHELON Oval V6.2 MRI System received FDA 510(k) clearance on 2023-01-26, under approval number K221619.
What company makes ECHELON Oval V6.2 MRI System?
ECHELON Oval V6.2 MRI System is manufactured by Fujifilm Healthcare Corporation.
What is the FDA product code for ECHELON Oval V6.2 MRI System?
The FDA product code for ECHELON Oval V6.2 MRI System is LNH.
Other Devices by Fujifilm Healthcare Corporation
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.