FDA 510(k)

syngo. CT 単源双エネルギー（ツインビーム）

K番号: K163289 · 2017-02-09

申請者Siemens Medical Solutions USA, Inc., Ultrasound DI

決定日2017-02-09

製品コードJAK

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

syngo. CT Single Source Dual Energy (twin beam) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K163289. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the syngo. CT Single Source Dual Energy (twin beam)?

syngo. CT Single Source Dual Energy (twin beam) is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. The 510(k) number is K163289.

When did syngo. CT Single Source Dual Energy (twin beam) receive FDA 510(k) clearance?

syngo. CT Single Source Dual Energy (twin beam) received FDA 510(k) clearance on 2017-02-09, under 510(k) number K163289.

Who is the listed applicant for syngo. CT Single Source Dual Energy (twin beam)?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc., Ultrasound DI as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for syngo. CT Single Source Dual Energy (twin beam)?

The FDA product code for syngo. CT Single Source Dual Energy (twin beam) is JAK.

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syngo. CT 単源双エネルギー（ツインビーム）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：JAK）

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