The following data is part of a premarket notification filed by Ziehm Imaging, Inc. with the FDA for Ziehm Vision Fd Digital Mobile Imaging System.
| Device ID | K061534 |
| 510k Number | K061534 |
| Device Name: | ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | ZIEHM IMAGING, INC. 4181 LATHAM ST. Riverside, CA 92501 |
| Contact | Richard Westrich |
| Correspondent | Richard Westrich ZIEHM IMAGING, INC. 4181 LATHAM ST. Riverside, CA 92501 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-02 |
| Decision Date | 2006-07-07 |
| Summary: | summary |