Csmc Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100714 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 Application Model 2010-01 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 application is intended for use in radiology settings and is supplied as a standalone digital tool. It is classified as a Class II device under FDA regulations and has received FDA 510K clearance and MDR authorization. The application operates on standard computing platforms and requires no physical sterilization or single-use considerations. Compatibility with various nuclear imaging modalities is supported through its integration with multiple FEI numbers, ensuring broad applicability in clinical workflows.
Frequently asked questions
What clinical applications does the CSMC Cardiac Suite Nuclear Medicine Software Application support, and how does it assist in patient care?
The CSMC Cardiac Suite Nuclear Medicine Software Application Model 2010-01 is specifically designed for nuclear cardiology imaging, processing and analyzing data from myocardial perfusion imaging (MPI) and related nuclear medicine studies. It helps assess cardiac function, identify perfusion defects, and evaluate myocardial viability, which are critical for diagnosing and managing coronary artery disease and other cardiac conditions. By providing detailed quantitative and qualitative analyses, it aids clinicians in making informed decisions about patient treatment plans.
Is this software application compatible with multiple imaging modalities, and if so, which ones?
Yes, the CSMC Cardiac Suite is designed to integrate with a wide range of nuclear imaging modalities. Its compatibility is supported through integration with multiple FEI numbers, including those for systems like SPECT (Single Photon Emission Computed Tomography) and other nuclear medicine imaging devices. This broad compatibility ensures seamless integration into existing clinical workflows across various radiology settings.
How is the software supplied, and are there any special handling requirements like sterilization or single-use considerations?
The CSMC Cardiac Suite Nuclear Medicine Software Application is supplied as a standalone digital tool, meaning it does not require physical sterilization or adhere to single-use protocols. Since it operates on standard computing platforms, the primary handling requirement is ensuring proper software installation, updates, and system compatibility within the radiology environment.
What regulatory pathways has this software undergone, and what does that mean for its use in clinical settings?
The CSMC Cardiac Suite has received FDA 510K clearance and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for safety and effectiveness. This classification as a Class II device under FDA regulations indicates it has undergone rigorous review by the FDA’s Radiology (RA) advisory committee, ensuring its suitability for use in nuclear cardiology imaging and diagnostic workflows in radiology settings.
Does the software require any specific hardware or computing platform to operate effectively?
The CSMC Cardiac Suite is designed to operate on standard computing platforms, meaning it can run on typical radiology department hardware as long as it meets the system requirements for the software. No specialized hardware is required beyond what is commonly used for nuclear medicine imaging analysis, ensuring flexibility in integration with existing clinical infrastructure.
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 | K100714 | Class II | Active |
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Manufacturer
- Manufacturer
- Cedars-Sinai Medical Center
Sources (2)
- FDA 510(k) K100714 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026