The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm Vision Rfd 3d.
| Device ID | K202360 |
| 510k Number | K202360 |
| Device Name: | Ziehm Vision RFD 3D |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Ziehm Imaging GmbH Lina-Ammon-Strasse 10 Nuremberg, DE 90471 |
| Contact | Stefan Fidler |
| Correspondent | Steve Seeman Ziehm-Orthoscan, Inc. 14555 N. 82nd St. Scottsdale, AZ 85260 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | JAK |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-19 |
| Decision Date | 2020-09-16 |