The following data is part of a premarket notification filed by Ziehm Imaging, Inc. with the FDA for Ziehm Vision R Digital Mobile Imaging System.
| Device ID | K061203 |
| 510k Number | K061203 |
| Device Name: | ZIEHM VISION R 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 |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2006-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EZIEZIEHMVISIONR1 | K061203 | 000 |