The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Azurion R2.0.
| Device ID | K181830 |
| 510k Number | K181830 |
| Device Name: | Azurion R2.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
| Contact | Owen Callaghan |
| Correspondent | Owen Callaghan Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-09 |
| Decision Date | 2018-08-02 |
| Summary: | summary |