The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm Vision Rfd.
| Device ID | K203428 |
| 510k Number | K203428 |
| Device Name: | Ziehm Vision RFD |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Ziehm Imaging GmbH Lina-Ammon-Strasse 10 Nuremberg, DE 90471 |
| Contact | Stefan Fiedler |
| Correspondent | Steve Seeman Ziehm-Orthoscan, Inc. 14555 N. 82nd St. Scottsdale, AZ 85260 |
| Product Code | JAA |
| Subsequent Product Code | OWB |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-20 |
| Decision Date | 2021-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EZIEZIEHMVISIONRFD1 | K203428 | 000 |