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FDA 510(k)

Contour ProtégéAI+

K-Number: K253270 · 2026-03-27

ApplicantMim Software, Inc.
Decision Date2026-03-27
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Contour ProtégéAI+ 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 2026-03-27 under 510(k) number K253270. 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 ProtégéAI+?

Contour ProtégéAI+ is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Mim Software, Inc.. The 510(k) number is K253270.

When did Contour ProtégéAI+ receive FDA 510(k) clearance?

Contour ProtégéAI+ received FDA 510(k) clearance on 2026-03-27, under 510(k) number K253270.

Who is the listed applicant for Contour ProtégéAI+?

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 ProtégéAI+?

The FDA product code for Contour ProtégéAI+ 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.

K251883MIM – LesionID ProK250035Contour ProtégéAI+K243012MIM – Symphony HDR FusionK233620MIM - Centiloid ScalingK232862MIM – Monte Carlo DosimetryK232514MIM – Dose Analysis

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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.K260509AutoContour (RADAC V5)Radformation, 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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