Identifiers
- 510(k) Number
- K081262 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 DC Neuro is a medical imaging workstation designed for advanced neuroimaging analysis, including functional MRI (fMRI), diffusion/fiber tracking, dynamic and vessel analysis, and 3D visualization. It processes and interprets MRI data to support diagnostic and research applications in neurology and radiology.
This device is supplied as a standalone workstation and is intended for use in MRI-compatible environments. It is not described as single-use or reusable, and no sterility or regulatory status beyond FDA 510K clearance is specified. The system is authorized under FDA 510K clearance (K081262) and is classified under product code LLZ, with a decision date of June 17, 2008.
Frequently asked questions
What types of neuroimaging analyses can the DC Neuro workstation perform, and how might this benefit clinical or research settings?
The DC Neuro workstation is specifically designed to process and analyze advanced neuroimaging data, including functional MRI (fMRI), diffusion and fiber tracking, dynamic and vessel analysis, and 3D visualization. These capabilities support both diagnostic and research applications in neurology and radiology by enabling detailed examination of brain structures and functions, improving accuracy in patient assessment, and facilitating research into neurological conditions.
Is the DC Neuro workstation intended for standalone use, and what kind of environment should it be installed in?
Yes, the DC Neuro is supplied as a standalone workstation, meaning it does not require additional hardware beyond its own system for operation. It is explicitly intended for use in MRI-compatible environments, ensuring compatibility with existing MRI systems in clinical or research settings.
What is the regulatory pathway for the DC Neuro, and which advisory committee was involved in its evaluation?
The DC Neuro received FDA 510(k) clearance under the traditional review pathway, classified under product code LLZ (Radiology). Its evaluation was conducted by the Radiology (RA) Advisory Committee, with a decision date of June 17, 2008. The clearance was granted as substantially equivalent to a predicate device.
Does the DC Neuro workstation have any specific usage restrictions, such as single-use or sterility requirements?
The DC Neuro is not described as single-use or reusable, nor are there any specified sterility requirements. Since it is a standalone workstation for neuroimaging analysis—rather than a disposable or invasive device—these considerations do not apply. It is intended for use in controlled, non-sterile environments like MRI suites.
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: Invivo DC Neuro | allmed.wiki, PDF 510(K) SUMMARY - Food and Drug Administration, FDA 510(k) Applications Submitted by Invivo Corporation, INVIVO CORPORATION FDA Filings - FDA.report, Invivo-Corp FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081262 | Class II | Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
Sources (1)
- FDA 510(k) K081262 24 fields · synced Sep 19, 2026