K260780
- 510(k) number
- K260780
- Device name
- HeartFocus
- Applicant
- Deski FR
- Product code
- QJU — Image Acquisition And/Or Optimization Guided By Arti
- Decision date
- 2026-06-03
- Date received
- 2026-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K260780.pdf
Official FDA record: K260780
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.