FDA 510(k)

互锁圆形小视野准直器，Elekta集成

K号: K161984 · 2016-09-27

决定日期2016-09-27

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Aktina Medical Corporation为申报人的其他记录

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