BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)— 510(k) K232738

Substantially Equivalent

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

FDA 510(k) clearance K232738 for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002), Substantially Equivalent on 2024-05-31. Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla.

Clearance details

Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
Product code: Code IYE
Advisory panel: Radiology
Date received: 2023-09-07
Decision date: 2024-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.