FDA 510(k)

BioTraceIO ビジョン（V1.7）

K番号: K251931 · 2025-09-08

決定日2025-09-08

製品コードQTZ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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BioTraceIO ビジョン（V1.7）

医療機器の概要

よくある質問

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