AI-Rad Companion (Pulmonary)
K-Number: K233753 · 2024-03-21
ApplicantSiemens Healthcare GmbH
Decision Date2024-03-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AI-Rad Companion (Pulmonary) is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2024-03-21 under approval number K233753. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AI-Rad Companion (Pulmonary)?
AI-Rad Companion (Pulmonary) is a medical device that received FDA 510(k) clearance on 2024-03-21. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K233753.
When was AI-Rad Companion (Pulmonary) approved by the FDA?
AI-Rad Companion (Pulmonary) received FDA 510(k) clearance on 2024-03-21, under approval number K233753.
What company makes AI-Rad Companion (Pulmonary)?
AI-Rad Companion (Pulmonary) is manufactured by Siemens Healthcare GmbH.
What is the FDA product code for AI-Rad Companion (Pulmonary)?
The FDA product code for AI-Rad Companion (Pulmonary) is JAK.
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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.