510(k) K232686
- Device
- CorVista® System
- Applicant
- Corvista Health, Inc.
- 510(k) number
- K232686
- Product code
- QXX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-08
- Date received
- 2023-09-01
- Regulation
- 870.2380
- Classification name
- Coronary Artery Disease Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Gabrielle Zaeska
- Address
- 7144 13th Pl. NW, Suite 2200 Washington DC US 20012 20012
FDA Registration Numbers
- 3007829657
- 3033300766
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00869059000436 | CorVista® System with CAD Add-On | Analytics For Life Inc | 2024-04-19 |
| 00869059000429 | CorVista® System | Analytics For Life Inc | 2024-02-06 |