The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Azurion R2.1.
| Device ID | K200917 |
| 510k Number | K200917 |
| Device Name: | Azurion R2.1 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
| Contact | Michelle Campbell |
| Correspondent | Michelle Campbell 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 | 2020-04-06 |
| Decision Date | 2020-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838116740 | K200917 | 000 |
| 00884838099210 | K200917 | 000 |
| 00884838099227 | K200917 | 000 |
| 00884838099234 | K200917 | 000 |
| 00884838099241 | K200917 | 000 |
| 00884838099258 | K200917 | 000 |
| 00884838099265 | K200917 | 000 |
| 00884838099272 | K200917 | 000 |
| 00884838116757 | K200917 | 000 |
| 00884838116764 | K200917 | 000 |
| 00884838116771 | K200917 | 000 |
| 00884838116788 | K200917 | 000 |
| 00884838116801 | K200917 | 000 |
| 00884838116726 | K200917 | 000 |
| 00884838116733 | K200917 | 000 |
| 00884838099203 | K200917 | 000 |