The following data is part of a premarket notification filed by Ventripoint Diagnostics, Ltd. with the FDA for Ventripoint Medical System Plus (vms+) 3.0.
| Device ID | K191493 |
| 510k Number | K191493 |
| Device Name: | Ventripoint Medical System Plus (VMS+) 3.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Ventripoint Diagnostics, Ltd. 2 Sheppard Avenue East, Suite 605 Toronto, CA M2n 5y7 |
| Contact | Desmond Hirson |
| Correspondent | Desmond Hirson Ventripoint Diagnostics, Ltd. 2 Sheppard Avenue East, Suite 605 Toronto, CA M2n 5y7 |
| Product Code | LLZ |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-05 |
| Decision Date | 2019-10-16 |