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FDA 510(k)

BeamDose軟體(S080053);BEAMSCAN軟體,選項參考劑量學(S080054.002)

K 號:K232738 · 2024-05-31

決定日期2024-05-31
產品代碼IYE
諮詢委員會RA
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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其他以 Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

相關器械(代碼:IYE)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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