FDA 510(k)

작은 필드 애플리케이터

K-번호: K220883 · 2022-12-15

신청자Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

결정일2022-12-15

제품 코드LHN

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

결정대체적으로 동일

기기 요약

Small Field Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K220883. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Small Field Applicator?

Small Field Applicator is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The 510(k) number is K220883.

When did Small Field Applicator receive FDA 510(k) clearance?

Small Field Applicator received FDA 510(k) clearance on 2022-12-15, under 510(k) number K220883.

Who is the listed applicant for Small Field Applicator?

The FDA 510(k) record lists Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Small Field Applicator?

The FDA product code for Small Field Applicator is LHN.

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha를 신청인으로 등재한 기타 기록

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