K243065
- 510(k) number
- K243065
- Device name
- Cardiac Guidance
- Applicant
- Caption Health, Inc. CA · US
- Product code
- QJU — Image Acquisition And/Or Optimization Guided By Arti
- Decision date
- 2025-01-15
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K243065.pdf
Official FDA record: K243065
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.