CSMC Cardiac Suite Nuclear Medicine Software
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112474 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 CSMC Cardiac Suite Nuclear Medicine Software is a System, Tomography, Computed, Emission device designed for nuclear cardiology imaging. It processes and analyzes data from myocardial perfusion imaging (MPI) and other nuclear medicine studies to assess cardiac function, perfusion defects, and viability, aiding in the diagnosis and management of coronary artery disease and other cardiac conditions.
This software is intended for use in radiology departments and nuclear medicine laboratories, where it runs on compatible systems to interpret and quantify imaging data. Supplied as a standalone software solution, it is not single-use but requires periodic updates and maintenance. The device operates under FDA 510(k) clearance and MDR compliance, with no specific sterility or MRI safety requirements noted. No physical sizes or storage conditions are specified beyond standard IT infrastructure requirements.
Frequently asked questions
What clinical applications does the CSMC Cardiac Suite Nuclear Medicine Software support in cardiac imaging?
The software is designed specifically for nuclear cardiology imaging, processing and analyzing data from myocardial perfusion imaging (MPI) and other nuclear medicine studies. It helps assess cardiac function, identify perfusion defects, and evaluate myocardial viability, which aids in diagnosing and managing coronary artery disease and related cardiac conditions.
How is the CSMC Cardiac Suite Nuclear Medicine Software supplied and what are its maintenance requirements?
The software is supplied as a standalone digital solution, meaning it does not require physical packaging or sterilization. Since it runs on compatible IT systems, it requires periodic updates and routine maintenance to ensure optimal performance, though no specific sterility or MRI safety requirements are noted.
Is the CSMC Cardiac Suite Nuclear Medicine Software intended for single-use or repeated use in clinical settings?
The software is not single-use; it is designed for repeated use in radiology departments and nuclear medicine laboratories. It operates as a standalone solution on compatible systems, requiring updates and maintenance over time rather than being discarded after a single use.
What regulatory pathways has the CSMC Cardiac Suite Nuclear Medicine Software followed, and where can it be legally used?
The software has obtained FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). These approvals indicate it meets U.S. and EU regulatory standards for nuclear medicine imaging software, allowing its use in facilities adhering to these jurisdictions’ requirements.
Are there any special storage conditions or environmental requirements for the CSMC Cardiac Suite Nuclear Medicine Software?
No specific storage conditions are mentioned beyond standard IT infrastructure requirements. Since it is a software solution, it must be installed on compatible systems with appropriate hardware and network connectivity, but no special environmental controls (e.g., temperature, humidity) are noted.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K112474 | Class II | Active |
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Manufacturer
- Manufacturer
- Cedars-Sinai Medical Center
Sources (2)
- FDA 510(k) K112474 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026