FDA 510(k)

ソノブックシリーズ診断超音波システム

K番号: K170374 · 2017-06-06

決定日2017-06-06

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

SonoBook Series Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Chison Medical Imaging Co., Ltd.. It received FDA 510(k) clearance on 2017-06-06 under 510(k) number K170374. 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 SonoBook Series Diagnostic Ultrasound System?

SonoBook Series Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-06-06. The listed applicant is Chison Medical Imaging Co., Ltd.. The 510(k) number is K170374.

When did SonoBook Series Diagnostic Ultrasound System receive FDA 510(k) clearance?

SonoBook Series Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-06-06, under 510(k) number K170374.

Who is the listed applicant for SonoBook Series Diagnostic Ultrasound System?

The FDA 510(k) record lists Chison Medical Imaging Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SonoBook Series Diagnostic Ultrasound System?

The FDA product code for SonoBook Series Diagnostic Ultrasound System is IYN.

申請者としてChison Medical Imaging Co., Ltd.を記載するその他の記録

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