FDA 510(k)

Xario 200 诊断超音波システム V5.0

K番号: K162155 · 2016-11-01

決定日2016-11-01

製品コードIYN

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

Xario 200 Diagnostic Ultrasound System V5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162155. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Xario 200 Diagnostic Ultrasound System V5.0?

Xario 200 Diagnostic Ultrasound System V5.0 is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K162155.

When did Xario 200 Diagnostic Ultrasound System V5.0 receive FDA 510(k) clearance?

Xario 200 Diagnostic Ultrasound System V5.0 received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162155.

Who is the listed applicant for Xario 200 Diagnostic Ultrasound System V5.0?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xario 200 Diagnostic Ultrasound System V5.0?

The FDA product code for Xario 200 Diagnostic Ultrasound System V5.0 is IYN.

申請者としてToshibamedical Systems Corporationを記載するその他の記録

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