The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for 2d Quantitative Analysis.
| Device ID | K161839 |
| 510k Number | K161839 |
| Device Name: | 2D Quantitative Analysis |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2016-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838075863 | K161839 | 000 |