FDA 510(k)

BeamDose 소프트웨어 (S080053); BEAMSCAN 소프트웨어, 옵션 참조 dosimetry (S080054.002)

K-번호: K232738 · 2024-05-31

신청자Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

결정일2024-05-31

제품 코드IYE

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

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기기 요약

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232738. 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 BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)?

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. The 510(k) number is K232738.

When did BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) receive FDA 510(k) clearance?

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232738.

Who is the listed applicant for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)?

The FDA 510(k) record lists Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)?

The FDA product code for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is IYE.

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla를 신청인으로 등재한 기타 기록

K252258VERIQA RT EPID 3D

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