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FDA 510(k)

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K 號：K252091 · 2026-01-29

申請人Medicalvr B.V.
決定日期2026-01-29
產品代碼QIH
諮詢委員會RA
決定相當於

器材摘要

Surgical Reality Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Medicalvr B.V.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K252091. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Surgical Reality Viewer?

Surgical Reality Viewer is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Medicalvr B.V.. The 510(k) number is K252091.

When did Surgical Reality Viewer receive FDA 510(k) clearance?

Surgical Reality Viewer received FDA 510(k) clearance on 2026-01-29, under 510(k) number K252091.

Who is the listed applicant for Surgical Reality Viewer?

The FDA 510(k) record lists Medicalvr B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Reality Viewer?

The FDA product code for Surgical Reality Viewer is QIH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：QIH）

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。

K260055syngo.CT 脑量化Siemens Medical Solutions USA, Inc.K262390骨專家VisianaK261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC 軟體僅 / EchoPAC 插件（v211）GE Medical Systems Ultrasound and Primary Care DiagnosticsK261677人工智慧腎臟評估（AIRA）版本 1Aramis Global AI Consultancies, LLCK2608794DMINVIA, LLC

官方來源

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