The following data is part of a premarket notification filed by Orpheus Medical Ltd. with the FDA for Medicvod System.
| Device ID | K151737 |
| 510k Number | K151737 |
| Device Name: | MedicVOD System |
| Classification | System, Image Processing, Radiological |
| Applicant | Orpheus Medical Ltd. PO Box 15140 Haifa, IL 31905 |
| Contact | Asaf Omer |
| Correspondent | Ian Marsden Dohmen Life Sciences Services, LLC 11925 W I-70 Frontage Road North, Suite 900 Wheat Ridge, CO 80033 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-26 |
| Decision Date | 2016-02-25 |
| Summary: | summary |