About this listing
Cleerly Labs from Cleerly Inc appears on the U.S. FDA list of AI-enabled medical devices under submission K190868. It went through the 510(k) pathway, reviewed by the Radiology panel, with an FDA decision dated November 5, 2019. Its primary FDA product code is LLZ.
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 Labs
- Company
- Cleerly Inc
- Submission number
- K190868
- Pathway
- 510(k)
- Decision date
- Nov 5, 2019
- Specialty (lead panel)
- Radiology
- Primary product code
- LLZ
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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.