AI-Rad Companion Organs RT
K-Number: K242745 · 2025-03-27
ApplicantSiemens Healthcare GmbH
Decision Date2025-03-27
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
AI-Rad Companion Organs RT is a medical device manufactured by Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2025-03-27 under approval number K242745. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AI-Rad Companion Organs RT?
AI-Rad Companion Organs RT is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Siemens Healthcare GmbH. The 510(k) number is K242745.
When was AI-Rad Companion Organs RT approved by the FDA?
AI-Rad Companion Organs RT received FDA 510(k) clearance on 2025-03-27, under approval number K242745.
What company makes AI-Rad Companion Organs RT?
AI-Rad Companion Organs RT is manufactured by Siemens Healthcare GmbH.
What is the FDA product code for AI-Rad Companion Organs RT?
The FDA product code for AI-Rad Companion Organs RT is QKB.
Other Devices by Siemens Healthcare GmbH
Related Devices (Code: QKB)
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.