MAGNETOM Amira, MAGNETOM Sempra
K-Number: K183221 · 2019-02-14
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-02-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MAGNETOM Amira, MAGNETOM Sempra is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-02-14 under approval number K183221. 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 MAGNETOM Amira, MAGNETOM Sempra?
MAGNETOM Amira, MAGNETOM Sempra is a medical device that received FDA 510(k) clearance on 2019-02-14. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K183221.
When was MAGNETOM Amira, MAGNETOM Sempra approved by the FDA?
MAGNETOM Amira, MAGNETOM Sempra received FDA 510(k) clearance on 2019-02-14, under approval number K183221.
What company makes MAGNETOM Amira, MAGNETOM Sempra?
MAGNETOM Amira, MAGNETOM Sempra is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for MAGNETOM Amira, MAGNETOM Sempra?
The FDA product code for MAGNETOM Amira, MAGNETOM Sempra 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.