ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
FDA 510(k) clearance K252360 · decided 2026-03-28
Clearance details
- K-number
- K252360
- Device name
- ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
- Applicant
- Anumana, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-29
- Decision date
- 2026-03-28
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- SAT
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CorVista System with PH Add-On (K233666) | Analytics For Life, Inc. | 2024-04-05 |
Recalls involving this device
No recalls on record reference this clearance.