The following data is part of a premarket notification filed by Almana Medical Imaging with the FDA for Rfvision, Model 9.9d.
| Device ID | K080847 |
| 510k Number | K080847 |
| Device Name: | RFVISION, MODEL 9.9D |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | ALMANA MEDICAL IMAGING PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm, P.e |
| Correspondent | Daniel Kamm, P.e ALMANA MEDICAL IMAGING PO BOX 7007 Deerfield, IL 60015 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-26 |
| Decision Date | 2008-08-06 |
| Summary: | summary |