The following data is part of a premarket notification filed by Almana Medical Imaging with the FDA for Dr Vision Neo, Dr Vision Dou.
| Device ID | K080614 |
| 510k Number | K080614 |
| Device Name: | DR VISION NEO, DR VISION DOU |
| Classification | System, X-ray, Stationary |
| Applicant | ALMANA MEDICAL IMAGING PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm ALMANA MEDICAL IMAGING PO BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-05 |
| Decision Date | 2008-06-20 |
| Summary: | summary |