About this listing
Novasight Hybrid System from Conavi Medical, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K252945. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated April 17, 2026. Its primary FDA product code is OBJ.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- Novasight Hybrid System
- Company
- Conavi Medical, Inc.
- Submission number
- K252945
- Pathway
- 510(k)
- Decision date
- Apr 17, 2026
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- OBJ
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.