About this listing
HeartFlow Analysis from HeartFlow, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K213857. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated October 14, 2022. Its primary FDA product code is PJA.
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
- HeartFlow Analysis
- Company
- HeartFlow, Inc.
- Submission number
- K213857
- Pathway
- 510(k)
- Decision date
- Oct 14, 2022
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- PJA
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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.