NeuViz 16 Essence Multi-slice CT Scanner System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171198 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NeuViz 16 Essence Multi-slice CT Scanner System is a computed tomography (CT) imaging device designed for high-resolution cross-sectional imaging of the body. It employs multiple detector rows to acquire volumetric data, enabling detailed visualization of anatomical structures for diagnostic purposes in radiology.
This system is intended for use in clinical settings, including hospitals and diagnostic imaging centers, and is supplied as a reusable medical device. It is authorized under FDA 510K clearance and MDD compliance, with a product code JAK. The device requires proper installation, calibration, and maintenance in accordance with manufacturer guidelines to ensure accurate imaging and patient safety.
Frequently asked questions
What types of clinical environments is the NeuViz 16 Essence Multi-slice CT Scanner System intended for use in?
The NeuViz 16 Essence Multi-slice CT Scanner System is designed for use in clinical settings such as hospitals and diagnostic imaging centers. Its high-resolution cross-sectional imaging capabilities support detailed anatomical visualization, making it suitable for radiology departments where comprehensive diagnostic imaging is required.
How is the NeuViz 16 Essence Multi-slice CT Scanner System supplied, and is it intended for single-use or reuse?
The NeuViz 16 Essence is supplied as a reusable medical device, meaning it is built for repeated use in clinical environments after proper cleaning, calibration, and maintenance. Unlike single-use devices, it requires adherence to manufacturer guidelines for installation, servicing, and upkeep to ensure consistent performance and patient safety.
What regulatory pathways has the NeuViz 16 Essence Multi-slice CT Scanner System followed, and what does that mean for buyers?
The NeuViz 16 Essence has undergone FDA 510(k) clearance and complies with the MDD (Medical Device Directive). The FDA clearance under product code JAK (Radiology) confirms it meets U.S. safety and performance standards for CT scanners, while MDD compliance ensures alignment with European medical device regulations. Buyers should verify local regulatory requirements, as these approvals do not automatically extend to all markets.
What distinguishes the NeuViz 16 Essence from other CT scanners in terms of imaging capabilities?
The NeuViz 16 Essence is a multi-slice CT scanner featuring 16 detector rows, enabling it to acquire volumetric data more efficiently than single-slice systems. This design allows for faster scanning, higher-resolution cross-sectional images, and improved visualization of complex anatomical structures—ideal for detailed diagnostic evaluations in radiology.
Who is the manufacturer, and where can additional information or support be obtained?
The manufacturer of the NeuViz 16 Essence is Neusoft Medical Systems Co., Ltd., headquartered in Shenyang, China. For technical support, maintenance, or further details, buyers should contact the manufacturer directly via the provided address (#16, Shiji Rd., Hunnan Industrial Area, Shenyang, 110179, CN) or reach out to Shao Xiancheng, the designated contact, for inquiries.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171198 | Class II | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (2)
- FDA 510(k) K171198 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026