The following data is part of a premarket notification filed by Ptw-freiburg Physikalisch-technische-werkstaetten with the FDA for Beamscan Mr.
| Device ID | K191646 |
| 510k Number | K191646 |
| Device Name: | Beamscan MR |
| Classification | Accelerator, Linear, Medical |
| Applicant | PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychlau GmbH Loerracher Str. 7 Freiburg, DE 79115 |
| Contact | Sandor-csaba Ats |
| Correspondent | Sandor-csaba Ats PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychlau GmbH Loerracher Str. 7 Freiburg, DE 79115 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-20 |
| Decision Date | 2020-02-21 |