FDA AI Clearance Tracker/K252859
Cardiovascular · 510(k)
ZEUS Platform (FG0501US)
iRhythm Technologies, Inc.
- Device
- ZEUS Platform (FG0501US)
- Company
- iRhythm Technologies, Inc.
- Submission number
- K252859
- Pathway
- 510(k)
- Decision date
- May 29, 2026
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- DQK
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.