TruSPECT Radiological Image Processing Station
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212230 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TruSPECT Radiological Image Processing Station is a software-as-a-medical-device (SaMD) designed for processing and analyzing radiological images. It functions as a dedicated workstation for nuclear medicine imaging, including cardiac applications, enabling advanced image reconstruction and analysis to support diagnostic workflows.
This device is supplied as a software solution for integration into existing radiological systems and is intended for use in clinical settings such as hospitals, clinics, and cardiology centers. It is classified under the product code LLZ and holds FDA 510(k) clearance with a Special review designation, affirming its substantial equivalence to predicate devices. No sterility or single-use requirements are specified, as it operates as a reusable software platform.
Frequently asked questions
What clinical specialties or settings is the TruSPECT Radiological Image Processing Station primarily intended for use in?
The TruSPECT Radiological Image Processing Station is designed for clinical settings like hospitals, clinics, and cardiology centers, specifically for nuclear medicine imaging, including cardiac applications. Its advanced image reconstruction and analysis features support diagnostic workflows in these specialized environments.
How is the TruSPECT device supplied, and does it require any special handling like sterilization or single-use procedures?
The TruSPECT is supplied as a software-as-a-medical-device (SaMD) solution, meaning it is integrated into existing radiological systems rather than being a physical device. Since it operates as a reusable software platform, there are no sterility or single-use requirements—it does not need sterilization or disposal after use.
What type of regulatory review did the TruSPECT undergo, and what does that mean for its approval status?
The TruSPECT Radiological Image Processing Station underwent a Special Review through the FDA’s 510(k) process, with a Radiology Advisory Committee (RA) review. This designation confirms its substantial equivalence to a predicate device, ensuring it meets regulatory standards for nuclear medicine imaging software in the U.S. market.
Can this device be used with any existing radiological imaging systems, or does it require specific hardware compatibility?
The TruSPECT is designed as a software solution for integration into existing radiological systems, meaning it is not a standalone hardware device. While the exact compatibility requirements aren’t detailed in the data, its classification under product code LLZ (Radiological Imaging) suggests it is intended to work with nuclear medicine imaging systems, though users should verify system-specific integration guidelines with Spectrum Dynamics Medical.
What distinguishes the TruSPECT from other radiological image processing tools, particularly in cardiac imaging?
The TruSPECT specializes in advanced image reconstruction and analysis for nuclear medicine imaging, particularly in cardiac applications. Unlike generic radiological tools, it is explicitly designed to enhance diagnostic workflows in nuclear cardiology by providing tailored processing and analysis capabilities for cardiac-specific imaging data.
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: Home Page - spectrum-dynamics, TruSPECT Radiological Image Processing Station Review: Pricing, FDA ..., PDF Spectrum Dynamics Medical Ltd August 16, 2021 Igor Naroditsky Vice ...
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 | K212230 | Class II | Active |
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Manufacturer
- Manufacturer
- Spectrum Dynamics Medical ltd
- FDA Applicant
- Spectrum Dynamics Medical, Ltd.
Sources (2)
- FDA 510(k) K212230 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026