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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 a medical device manufactured by Mvision AI OY. It received FDA 510(k) clearance on 2024-10-18 under approval 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. It is manufactured by Mvision AI OY. The 510(k) number is K241490.

When was Contour+ (MVision AI Segmentation) approved by the FDA?

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

What company makes Contour+ (MVision AI Segmentation)?

Contour+ (MVision AI Segmentation) is manufactured by Mvision AI OY.

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

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

Other Devices by Mvision AI OY

K250064Dose+ (1.0)

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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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