FDA 510(k)

Synergy 플랫폼, Synergy, 인피니티, VersaHD

K-번호: K192242 · 2019-11-22

결정일2019-11-22

제품 코드IYE

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

결정대체적으로 동일

기기 요약

Synergy Platform, Synergy, Infinity, VersaHD is the device name listed in this FDA 510(k) record. The listed applicant is Elekta Limited. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K192242. 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 Synergy Platform, Synergy, Infinity, VersaHD?

Synergy Platform, Synergy, Infinity, VersaHD is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Elekta Limited. The 510(k) number is K192242.

When did Synergy Platform, Synergy, Infinity, VersaHD receive FDA 510(k) clearance?

Synergy Platform, Synergy, Infinity, VersaHD received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192242.

Who is the listed applicant for Synergy Platform, Synergy, Infinity, VersaHD?

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

What is the FDA product code for Synergy Platform, Synergy, Infinity, VersaHD?

The FDA product code for Synergy Platform, Synergy, Infinity, VersaHD is IYE.

Elekta Limited를 신청인으로 등재한 기타 기록

K210500엘렉타 시너지, 엘렉타 하모니, 엘렉타 인피니티, 베르사 HD K192482엘렉타 유니티 K182076엘렉타 유니티

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