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FDA 510(k)

AI-Rad Companion Organs RT

K-Number: K232899 · 2024-04-03

ApplicantSiemens Medical Solutions U.S.A.
Decision Date2024-04-03
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-Rad Companion Organs RT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions U.S.A.. It received FDA 510(k) clearance on 2024-04-03 under 510(k) number K232899. 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 2024-04-03. The listed applicant is Siemens Medical Solutions U.S.A.. The 510(k) number is K232899.

When did AI-Rad Companion Organs RT receive FDA 510(k) clearance?

AI-Rad Companion Organs RT received FDA 510(k) clearance on 2024-04-03, under 510(k) number K232899.

Who is the listed applicant for AI-Rad Companion Organs RT?

The FDA 510(k) record lists Siemens Medical Solutions U.S.A. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Siemens Medical Solutions U.S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232305AI-Rad Companion Brain MRK222360AI-Rad Companion (Cardiovascular)

Related Devices (Code: QKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262452AutoContour (RADAC V6)Radformation, Inc.K261306AI Contouring (VA10A)Varian Medical SystemsK260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbHK252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K253270Contour ProtégéAI+Mim Software, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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