FDA 510(k)

連鎖円形小視野コリメータ、Elekta Integrated

K番号: K161984 · 2016-09-27

決定日2016-09-27

製品コードIYE

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

Interlocked Circular Small Field Collimators, Elekta Integrated is the device name listed in this FDA 510(k) record. The listed applicant is Aktina Medical Corporation. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K161984. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Interlocked Circular Small Field Collimators, Elekta Integrated?

Interlocked Circular Small Field Collimators, Elekta Integrated is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Aktina Medical Corporation. The 510(k) number is K161984.

When did Interlocked Circular Small Field Collimators, Elekta Integrated receive FDA 510(k) clearance?

Interlocked Circular Small Field Collimators, Elekta Integrated received FDA 510(k) clearance on 2016-09-27, under 510(k) number K161984.

Who is the listed applicant for Interlocked Circular Small Field Collimators, Elekta Integrated?

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

What is the FDA product code for Interlocked Circular Small Field Collimators, Elekta Integrated?

The FDA product code for Interlocked Circular Small Field Collimators, Elekta Integrated is IYE.

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

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