The following data is part of a premarket notification filed by Orpheus Medical, Ltd. with the FDA for Medicvod, Medicast, Medishow, Medisearch, Central Storage System - Css.
| Device ID | K123426 |
| 510k Number | K123426 |
| Device Name: | MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS |
| Classification | System, Image Processing, Radiological |
| Applicant | ORPHEUS MEDICAL, LTD. 11925 WEST I-70 FRONTAGE RD. STE 900 Wheat Ridge, CO 80033 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo ORPHEUS MEDICAL, LTD. 11925 WEST I-70 FRONTAGE RD. STE 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 | 2012-11-07 |
| Decision Date | 2013-03-01 |
| Summary: | summary |