K242807
- 510(k) number
- K242807
- Device name
- HeartFocus (V.1.1.1)
- Applicant
- Deski FR
- Product code
- QJU — Image Acquisition And/Or Optimization Guided By Arti
- Decision date
- 2025-04-04
- Date received
- 2024-09-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242807.pdf
Official FDA record: K242807
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.