The following data is part of a premarket notification filed by Ziehm Imaging, Inc. with the FDA for Ziehm Vision 2.
| Device ID | K073346 |
| 510k Number | K073346 |
| Device Name: | ZIEHM VISION 2 |
| Classification | System, X-ray, Tomography, Computed |
| 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 | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-29 |
| Decision Date | 2008-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EZIEZIEHMVISIONV3D1 | K073346 | 000 |
| EZIEZIEHMVISIONV1 | K073346 | 000 |
| EZIEZIEHMVISIONFDV3D1 | K073346 | 000 |
| EZIEZIEHMVISIONFDV1 | K073346 | 000 |
| EZIEZIEHMVISIONFD1 | K073346 | 000 |
| EZIEZIEHMVISION1 | K073346 | 000 |