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FDA 510(k)

BioTraceIO 頻道視覺 (V1.7)

K 號：K251931 · 2025-09-08

申請人Techsomed Medical Technologies
決定日期2025-09-08
產品代碼QTZ
諮詢委員會RA
決定相當於

器材摘要

BioTraceIO Vision (V1.7) is the device name listed in this FDA 510(k) record. The listed applicant is Techsomed Medical Technologies. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K251931. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioTraceIO Vision (V1.7)?

BioTraceIO Vision (V1.7) is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Techsomed Medical Technologies. The 510(k) number is K251931.

When did BioTraceIO Vision (V1.7) receive FDA 510(k) clearance?

BioTraceIO Vision (V1.7) received FDA 510(k) clearance on 2025-09-08, under 510(k) number K251931.

Who is the listed applicant for BioTraceIO Vision (V1.7)?

The FDA 510(k) record lists Techsomed Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioTraceIO Vision (V1.7)?

The FDA product code for BioTraceIO Vision (V1.7) is QTZ.

相關臨床試驗

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相關器械（代碼：QTZ）

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。

K253264我的消融導引器（VC10A）Siemens Healthcare GmbHK252947HistoSonics®規劃工具HistoSonics, Inc.K240796myAblation導引器（VB80A）Siemens Healthcare GmbHK240773VisAble.IOTechsomedK222222Artemis, Artemis TPO, Artemis MXEigenK222938Ablation-fitR.A.W. S.R.L

官方來源

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