Bunkerhill ECG-EF AI
Bunkerhill Health · bunkerhillhealth.com ↗
AI that estimates reduced ejection fraction from ECG.
AI status
AI product On FDA AI-enabled device list (K250649) · source
Compliance profile
| Field | Status | Detail | Source | Checked |
|---|---|---|---|---|
| FDA | Verified | 510(k) cleared · K250649 | accessdata.fda.gov | 2026-10-14 |
| HIPAA | Vendor-stated | Vendor states HIPAA compliance support | bunkerhillhealth.com | 2026-10-14 |
| BAA | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| SOC 2 | Vendor-stated | Vendor references a SOC 2 report (not reviewed by us) | bunkerhillhealth.com | 2026-10-14 |
| HITRUST | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| Epic integration | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
Vendor-stated means the claim appears on the vendor’s site; we have not audited it. Unverified means we found no source, which is not a negative finding. Vendors can request a correction.
FDA records
From the FDA AI-enabled medical devices list. Wording follows FDA: 510(k) “cleared”, De Novo “granted”. Clearance applies to the specific indication in the FDA record.
| Number | Device (as listed) | Pathway | Decision date | Panel |
|---|---|---|---|---|
| K250649 | Bunkerhill ECG-EF | 510(k) cleared | 09/19/2025 | Cardiovascular |
Alternatives
Information about software products for healthcare professionals. Not medical advice, not an endorsement. Verify all details with the vendor. We never collect patient information (PHI).