AI Rad Companion (Engine)
K-Number: K183272 · 2019-02-01
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-02-01
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 2019-02-01 under approval number K183272. 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 2019-02-01. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K183272.
When was AI Rad Companion (Engine) approved by the FDA?
AI Rad Companion (Engine) received FDA 510(k) clearance on 2019-02-01, under approval number K183272.
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.
Other Devices by Siemens Medical Solutions USA, Inc.
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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.