The following data is part of a premarket notification filed by Fischer Imaging Corp. with the FDA for Mobile C-arm Omni 325.
| Device ID | K880518 |
| 510k Number | K880518 |
| Device Name: | MOBILE C-ARM OMNI 325 |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Contact | Richard Lucas |
| Correspondent | Richard Lucas FISCHER IMAGING CORP. 12300 NORTH GRANT ST. Denver, CO 80241 -3120 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-03-09 |