About this listing
Cleerly LABS (v2.0) from Cleerly, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K242338. It went through the 510(k) pathway, reviewed by the Radiology panel, with an FDA decision dated March 7, 2025. Its primary FDA product code is QIH.
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 (v2.0)
- Company
- Cleerly, Inc.
- Submission number
- K242338
- Pathway
- 510(k)
- Decision date
- Mar 7, 2025
- Specialty (lead panel)
- Radiology
- Primary product code
- QIH
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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.