Identifiers
- 510(k) Number
- K142697 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 NExCT 7 is a portable computed tomography (CT) scanner manufactured by Neurologica Corporation. It is designed to provide diagnostic imaging capabilities in various clinical settings.
The NExCT 7 is supplied as a reusable device and is not specified as MRI safe. It is authorized under FDA 510K clearance with product code JAK and K-number K142697. The device is intended for use in radiology applications.
Frequently asked questions
What is the NExCT 7 used for?
The NExCT 7 is a portable computed tomography scanner designed to provide diagnostic imaging capabilities in various clinical settings, particularly in radiology applications.
Is the NExCT 7 a single-use or reusable device?
The NExCT 7 is supplied as a reusable device, meaning it can be used multiple times for patient imaging procedures.
What is the regulatory status of the NExCT 7?
The NExCT 7 is authorized under FDA 510K clearance with product code JAK and K-number K142697, having been determined substantially equivalent to predicate devices.
Is the NExCT 7 MRI safe?
The NExCT 7 is not specified as MRI safe, so it should not be used in MRI environments without specific validation.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142697 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurologica Corporation
Sources (1)
- FDA 510(k) K142697 24 fields · synced Oct 6, 2026