AI-Rad Companion Brain MR
K-Number: K193290 · 2020-06-17
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-06-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AI-Rad Companion Brain MR is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-06-17 under approval number K193290. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AI-Rad Companion Brain MR?
AI-Rad Companion Brain MR is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K193290.
When was AI-Rad Companion Brain MR approved by the FDA?
AI-Rad Companion Brain MR received FDA 510(k) clearance on 2020-06-17, under approval number K193290.
What company makes AI-Rad Companion Brain MR?
AI-Rad Companion Brain MR is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for AI-Rad Companion Brain MR?
The FDA product code for AI-Rad Companion Brain MR is LLZ.
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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.