FDA 510(k)

Contour ProtégéAI+

K号: K253270 · 2026-03-27

决定日期2026-03-27

产品代码QKB

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Mim Software, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251883MIM – LesionID Pro K250035Contour ProtégéAI+K243012MIM – Symphony HDR Fusion K233620MIM - Centiloid Scaling K232862MIM – Monte Carlo Dosimetry K232514MIM – Dose Analysis

查看所有 19 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。