The following data is part of a premarket notification filed by Medphoton Gmbh with the FDA for Imagingring System On Rails.
| Device ID | K191267 |
| 510k Number | K191267 |
| Device Name: | ImagingRing System On Rails |
| Classification | Accelerator, Linear, Medical |
| Applicant | MedPhoton GmbH Strubergasse 16 Salzburg, AT 5020 |
| Contact | Daniel Schaffarzick |
| Correspondent | Daniel Schaffarzick MedPhoton GmbH Strubergasse 16 Salzburg, AT 5020 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2019-08-01 |