The following data is part of a premarket notification filed by Medvoxel Systems Inc with the FDA for Medvoxel Heartpro Software Application.
| Device ID | K103565 |
| 510k Number | K103565 |
| Device Name: | MEDVOXEL HEARTPRO SOFTWARE APPLICATION |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDVOXEL SYSTEMS INC 2867 CROSSCURRENT DRIVE Mississauga, CA L5n 6l1 |
| Contact | Bonnie Sewlochan |
| Correspondent | Bonnie Sewlochan MEDVOXEL SYSTEMS INC 2867 CROSSCURRENT DRIVE Mississauga, CA L5n 6l1 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-04-12 |
| Summary: | summary |