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FDA 510(k)

Contour ProtegeAI

K-Number: K210632 · 2021-10-20

ApplicantMim Software, Inc.
Decision Date2021-10-20
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Contour ProtegeAI is the device name listed in this FDA 510(k) record. The listed applicant is Mim Software, Inc.. It received FDA 510(k) clearance on 2021-10-20 under 510(k) number K210632. 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 Contour ProtegeAI?

Contour ProtegeAI is a medical device that received FDA 510(k) clearance on 2021-10-20. The listed applicant is Mim Software, Inc.. The 510(k) number is K210632.

When did Contour ProtegeAI receive FDA 510(k) clearance?

Contour ProtegeAI received FDA 510(k) clearance on 2021-10-20, under 510(k) number K210632.

Who is the listed applicant for Contour ProtegeAI?

The FDA 510(k) record lists Mim Software, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Contour ProtegeAI?

The FDA product code for Contour ProtegeAI is QKB.

Other records listing Mim Software, Inc. 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.

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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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