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FDA 510(k)

Contour+ (MVision AI Segmentation)

K-Number: K241490 · 2024-10-18

ApplicantMvision AI OY
Decision Date2024-10-18
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Contour+ (MVision AI Segmentation) is the device name listed in this FDA 510(k) record. The listed applicant is Mvision AI OY. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K241490. 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+ (MVision AI Segmentation)?

Contour+ (MVision AI Segmentation) is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Mvision AI OY. The 510(k) number is K241490.

When did Contour+ (MVision AI Segmentation) receive FDA 510(k) clearance?

Contour+ (MVision AI Segmentation) received FDA 510(k) clearance on 2024-10-18, under 510(k) number K241490.

Who is the listed applicant for Contour+ (MVision AI Segmentation)?

The FDA 510(k) record lists Mvision AI OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Contour+ (MVision AI Segmentation)?

The FDA product code for Contour+ (MVision AI Segmentation) is QKB.

Other records listing Mvision AI OY 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.

K250064Dose+ (1.0)

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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