The following data is part of a premarket notification filed by Medphoton Gmbh with the FDA for Imagingring System.
| Device ID | K161400 |
| 510k Number | K161400 |
| Device Name: | ImagingRing System |
| 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 | 2016-05-20 |
| Decision Date | 2016-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19120075320037 | K161400 | 000 |
| 19120075320013 | K161400 | 000 |