About this listing
Cleerly ISCHEMIA from Cleerly, Inc appears on the U.S. FDA list of AI-enabled medical devices under submission K231335. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated September 8, 2023. Its primary FDA product code is QXZ.
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
- Cleerly ISCHEMIA
- Company
- Cleerly, Inc
- Submission number
- K231335
- Pathway
- 510(k)
- Decision date
- Sep 8, 2023
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- QXZ
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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.