The following data is part of a premarket notification filed by Omega Medical Imaging, Inc. with the FDA for Cs-series Fluoroscopy System, Cs-10 Through Cs-65 (11 Configurations).
| Device ID | K070834 |
| 510k Number | K070834 |
| Device Name: | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Contact | James A Princehorn |
| Correspondent | James A Princehorn OMEGA MEDICAL IMAGING, INC. 675 HICKMAN CIRCLE Sanford, FL 32771 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-27 |
| Decision Date | 2007-05-18 |
| Summary: | summary |