The following data is part of a premarket notification filed by Medphoton Gmbh with the FDA for Mobile Imagingring System, Irm, Loop-x Mobile Imaging Robot, Loop-x.
| Device ID | K203281 |
| 510k Number | K203281 |
| Device Name: | Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | medPhoton GmbH Karolingerstraße 16 Salzburg, AT 5020 |
| Contact | Daniel Schaffarzick |
| Correspondent | Daniel Schaffarzick medPhoton GmbH Karolingerstraße 16 Salzburg, AT 5020 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-06 |
| Decision Date | 2020-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19120075320075 | K203281 | 000 |
| 19120075320068 | K203281 | 000 |