SyMRI
K-Number: K162943 · 2017-08-29
ApplicantSyntheticmr AB
Decision Date2017-08-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SyMRI is a medical device manufactured by Syntheticmr AB. It received FDA 510(k) clearance on 2017-08-29 under approval number K162943. 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 SyMRI?
SyMRI is a medical device that received FDA 510(k) clearance on 2017-08-29. It is manufactured by Syntheticmr AB. The 510(k) number is K162943.
When was SyMRI approved by the FDA?
SyMRI received FDA 510(k) clearance on 2017-08-29, under approval number K162943.
What company makes SyMRI?
SyMRI is manufactured by Syntheticmr AB.
What is the FDA product code for SyMRI?
The FDA product code for SyMRI is LNH.
Other Devices by Syntheticmr AB
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K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
Official Source
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