K243881
- 510(k) number
- K243881
- Device name
- HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
- Applicant
- Bracco Diagnostics, Inc. NJ · US
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-03-03
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243881.pdf
Official FDA record: K243881
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.