The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Azurion Series R1.2.
| Device ID | K172822 |
| 510k Number | K172822 |
| Device Name: | Azurion Series R1.2 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederland BV Veenpluis 4-6 Best, NL 5684pc |
| Contact | Jeanette Becker |
| Correspondent | Jeanette Becker 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 | 2017-09-18 |
| Decision Date | 2017-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838085367 | K172822 | 000 |
| 00884838085350 | K172822 | 000 |