FDA 510(k)

교차형 원형 소형 필터, Elekta 통합

K-번호: K161984 · 2016-09-27

결정일2016-09-27

제품 코드IYE

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Aktina Medical Corporation를 신청인으로 등재한 기타 기록

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