HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coron…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243881 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HeartSee Cardiac PET Processing Software Version 4 is a medical imaging analysis system for quantitative assessment of myocardial perfusion and coronary flow reserve (CFR) using PET scans. It evaluates regional and global perfusion in cc/min/g and generates coronary flow capacity (CFC) maps to assist radiologists in interpreting perfusion images for patients with suspected or known coronary artery disease (CAD).
Supplied as a digital product for installation on compatible workstations, this software is classified as a Class II device with FDA 510(k) clearance. It is compatible with multiple PET scanner models (FEI numbers provided) and is reusable, requiring adherence to standard IT security and data protection protocols. No sterility or single-use requirements apply.
Frequently asked questions
What is the HeartSee Cardiac PET Processing Software Version 4 used for?
The HeartSee Cardiac PET Processing Software Version 4 is designed for quantitative assessment of myocardial perfusion and coronary flow reserve (CFR) using PET scans. It evaluates both regional and global perfusion in cc/min/g and generates coronary flow capacity (CFC) maps. These features help radiologists interpret perfusion images more accurately for patients with suspected or known coronary artery disease (CAD).
How is the HeartSee Cardiac PET Software supplied and installed?
The software is supplied as a digital product, intended for installation on compatible workstations. It does not require physical packaging or sterility measures, as it is purely software-based. Installation instructions are provided by Bracco Diagnostics to ensure proper setup on supported systems.
Is the HeartSee Cardiac PET Software reusable or single-use?
The software is reusable and does not have a single-use requirement. However, since it is a digital product, adherence to standard IT security and data protection protocols is mandatory to ensure proper functionality and compliance with regulatory standards.
Which PET scanners is the HeartSee Cardiac PET Software compatible with?
The HeartSee Cardiac PET Processing Software Version 4 is compatible with a wide range of PET scanners, identified by the following FEI numbers: 3015232217, 3002808139, 3012085143, and many others (a full list is available in the specifications). This broad compatibility ensures flexibility for radiology departments using different PET scanner models.
What regulatory clearance does the HeartSee Cardiac PET Software hold?
The HeartSee Cardiac PET Processing Software Version 4 holds FDA 510(k) clearance, classified as a Class II medical device. This clearance indicates that the software has been deemed substantially equivalent to a legally marketed predicate device, meeting the necessary regulatory requirements for use in clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion ..., HeartSee™ - We Are Cardiac Pet®, Bracco's HeartSee: New Features for CAD Diagnosis and Ease of Use
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243881 | Class II | Active |
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Manufacturer
- Manufacturer
- Bracco Diagnostics Inc.
- FDA Applicant
- Bracco Diagnostics, Inc.
Sources (1)
- FDA 510(k) K243881 24 fields · synced Oct 1, 2026