Class Class II

Contour+ (MVision AI Segmentation) (K241490)

K241490 2024-10-18 Traditional
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Description

Contour+ (MVision AI Segmentation) by Mvision AI OY, an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241490
Clearance Date2024-10-18
Clearance TypeTraditional
Product CodeQKB
Regulation Number892.2050

Categories

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Predicate lineage for K241490

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Contour+ (MVision AI Segmentation) (K241490) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K212915MVision AI SegmentationMVision AI2022

Trace the full predicate network for K241490

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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