HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
FDA 510(k) clearance K243881 · decided 2025-03-03
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-18
- Decision date
- 2025-03-03
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.