The following data is part of a premarket notification filed by Ziehm Imaging Gmbh with the FDA for Ziehm Vision Rfd 3d.
| Device ID | K142740 |
| 510k Number | K142740 |
| Device Name: | Ziehm Vision RFD 3D |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | ZIEHM IMAGING GMBH DONAUSTRASSE 31 Nuremberg, DE D-90451 |
| Contact | Stefan Fiedler |
| Correspondent | Richard L Westrich ZIEHM IMAGING GMBH 6280 HAZELTINE NATIONAL DR. Orlando, FL 32822 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-24 |
| Decision Date | 2015-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EZIEZIEHMVISIONRFD3D1 | K142740 | 000 |