K232738
- 510(k) number
- K232738
- Device name
- BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
- Applicant
- Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla DE
- Product code
- IYE — Accelerator, Linear, Medical
- Decision date
- 2024-05-31
- Date received
- 2023-09-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232738.pdf
Official FDA record: K232738
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.