Clearance Summary
BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) received FDA 510(k) clearance under submission number K232738, sponsored by Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2024-05-31.
- Submission: K232738
- Applicant / Sponsor: Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2024-05-31
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.