The following data is part of a premarket notification filed by Medis Medical Imaging Systems Bv with the FDA for Qangio Xa 3d.
| Device ID | K182611 |
| 510k Number | K182611 |
| Device Name: | Qangio XA 3D |
| Classification | X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device |
| Applicant | Medis Medical Imaging Systems Bv Schuttersveld 9 Leiden, NL 2316 Xg |
| Contact | B. Goedhart |
| Correspondent | B. Goedhart Medis Medical Imaging Systems Bv Schuttersveld 9 Leiden, NL 2316 Xg |
| Product Code | QHA |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2019-05-30 |