FDA 510(k)

Radiance 330 Proton Beam Therapy System

K-번호: K191521 · 2019-09-27

신청자Protom International Holding Corporation

결정일2019-09-27

제품 코드LHN

자문 위원회RA

결정Substantially Equivalent

기기 요약

Radiance 330 Proton Beam Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Protom International Holding Corporation. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K191521. 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 Radiance 330 Proton Beam Therapy System?

Radiance 330 Proton Beam Therapy System is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Protom International Holding Corporation. The 510(k) number is K191521.

When did Radiance 330 Proton Beam Therapy System receive FDA 510(k) clearance?

Radiance 330 Proton Beam Therapy System received FDA 510(k) clearance on 2019-09-27, under 510(k) number K191521.

Who is the listed applicant for Radiance 330 Proton Beam Therapy System?

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

What is the FDA product code for Radiance 330 Proton Beam Therapy System?

The FDA product code for Radiance 330 Proton Beam Therapy System is LHN.

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Radiance 330 Proton Beam Therapy System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LHN)

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