AI-Rad Companion Engine
K-Number: K193294 · 2020-07-10
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-07-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AI-Rad Companion Engine is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-07-10 under approval number K193294. 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 Engine?
AI-Rad Companion Engine is a medical device that received FDA 510(k) clearance on 2020-07-10. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K193294.
When was AI-Rad Companion Engine approved by the FDA?
AI-Rad Companion Engine received FDA 510(k) clearance on 2020-07-10, under approval number K193294.
What company makes AI-Rad Companion Engine?
AI-Rad Companion Engine is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for AI-Rad Companion Engine?
The FDA product code for AI-Rad Companion Engine 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.