K253535
- 510(k) number
- K253535
- Device name
- Ligence Heart
- Applicant
- Ligence Uab LT
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-02-27
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K253535
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.