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FDA 510(k)

AI-Rad Companion Organs RT

K-Number: K221305 · 2022-10-14

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2022-10-14
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 USA, Inc.. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K221305. 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 2022-10-14. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K221305.

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

AI-Rad Companion Organs RT received FDA 510(k) clearance on 2022-10-14, under 510(k) number K221305.

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

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. 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.

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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

View on FDA Database →

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

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