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US
Last updated May 25, 2026
What SYNTERMED INCORPORATED makes
Syntermed Incorporated develops software applications for managing and interpreting medical imaging data across multiple specialties, including cardiovascular risk assessment and neurosurgical planning. Their portfolio includes tools like the Emory Cardiac Toolbox, which supports cardiovascular risk evaluation, and NeuroQ, a software application for neurosurgical ultrasound navigation. These products integrate with imaging systems to assist clinicians in diagnostic and procedural workflows.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are designed for use in the United States, adhering to applicable medical device standards and regulatory requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Syntermed Incorporated manufacture?
Syntermed Incorporated specializes in developing software applications for medical imaging. Their products include multidisciplinary medical image management software, cardiovascular risk evaluation interpretive software (such as the Emory Cardiac Toolbox), and neurosurgical ultrasound navigation system applications (like NeuroQ). These tools are designed to assist clinicians in interpreting imaging data, assessing cardiovascular risks, and planning neurosurgical procedures.
Where is Syntermed Incorporated based, and where are their devices primarily used?
Syntermed Incorporated is based in the United States. Their devices are developed with a focus on the U.S. market, where they are utilized in clinical settings to support diagnostic and procedural workflows across specialties like cardiology and neurosurgery.
Which regulatory registries list Syntermed Incorporated’s devices?
Syntermed Incorporated’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of their medical devices, which are classified under FDA’s regulatory framework.
How are Syntermed Incorporated’s devices classified under FDA regulations?
Syntermed Incorporated’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as software applications for medical imaging interpretation and procedural guidance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 113727205
Catalogue (18)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Emory Cardiac Toolbox | 4.2.7003.28586 | FDA UDI | Class II | Active |
| NeuroQ | 4.1.0036-r20250714 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.2.8851.24480 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.27720.29473 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.28706.22036 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.27720.29473 | FDA UDI | Class II | Active |
| NeuroQ | 4.0.9995-r20250516 | FDA UDI | Class II | Active |
| NeuroQ | 3.6.20131127 | FDA UDI | Class II | Active |
| NeuroQ | 3.8 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.2.9312.29770 | FDA UDI | Class II | Active |
| NeuroQ | 3.75.20171019 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.2.8339.22556 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.2.9214.18548 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.0.5121.18001 | FDA UDI | Class II | Active |
| NeuroQ | 4.0.9993.r20250312 | FDA UDI | Class II | Active |
| Emory Cardiac Toolbox | 4.2.7559.13747 | FDA UDI | Class II | Active |
| NeuroQ | 4.0.991.r11 | FDA UDI | Class II | Active |
| NeuroQ | 3.80.20210429.143255 | FDA UDI | Class II | Active |
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