The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for Allura Xper R9.
| Device ID | K163715 |
| 510k Number | K163715 |
| Device Name: | Allura Xper R9 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Jeanette Becker |
| Correspondent | Jeanette Becker PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 Best, NL 5684 Pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-30 |
| Decision Date | 2017-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838085282 | K163715 | 000 |
| 00884838085275 | K163715 | 000 |
| 00884838085268 | K163715 | 000 |
| 00884838085251 | K163715 | 000 |
| 00884838083448 | K163715 | 000 |
| 00884838083431 | K163715 | 000 |