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FDA 510(k)

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

K-Number: K232738 · 2024-05-31

ApplicantPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
Decision Date2024-05-31
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is a medical device manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. It received FDA 510(k) clearance on 2024-05-31 under approval number K232738. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. The 510(k) number is K232738.

When was BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) approved by the FDA?

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

What company makes BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)?

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is manufactured by Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla.

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.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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