FDA 510(k)

RT-Mind-AI

K-Number: K213155 · 2021-12-15

Decision Date2021-12-15

Product CodeQKB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RT-Mind-AI is the device name listed in this FDA 510(k) record. The listed applicant is Medmind Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K213155. 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 RT-Mind-AI?

RT-Mind-AI is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Medmind Technology Co., Ltd.. The 510(k) number is K213155.

When did RT-Mind-AI receive FDA 510(k) clearance?

RT-Mind-AI received FDA 510(k) clearance on 2021-12-15, under 510(k) number K213155.

Who is the listed applicant for RT-Mind-AI?

The FDA 510(k) record lists Medmind Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT-Mind-AI?

The FDA product code for RT-Mind-AI is QKB.

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 Systems K260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH K252190DeepBT 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.