510(k) K232738
K232738 is an FDA 510(k) premarket notification submitted by Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla for the device "BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2024
- Date Received
- September 7, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accelerator, Linear, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type