FDA 510(k)

Contour+ (MVision AI 分割)

K 號：K241490 · 2024-10-18

決定日期2024-10-18

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Mvision AI OY 為申請人之記錄

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K250064Dose+（1.0）

相關器械（代碼：QKB）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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