Identifiers
- 510(k) Number
- K090811 FDA 510(k)
- FDA Product Code
- KPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1200 FDA 510(k)
- Regulation Number
- 892.1200 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Inspira Hd, Model: Nl1000 is a computed tomography system, specifically a single photon computed tomography system, designed for imaging. It is a mobile system comprised of focused collimators to acquire images.
The Inspira Hd, Model: Nl1000 is supplied as a portable system, primarily for brain imaging. It is a high-resolution system and is designed as a battery-powered device. The system has been assigned a product code of Kps and a regulation number of 892.1200.
Frequently asked questions
What is the Inspira HD, Model NL1000 used for?
The Inspira HD, Model NL1000 is used for brain imaging, specifically as a single photon computed tomography system, designed to acquire high-resolution images.
Is the Inspira HD, Model NL1000 a portable system?
Yes, the Inspira HD, Model NL1000 is supplied as a portable system, allowing for mobile use and convenience.
What is the power source of the Inspira HD, Model NL1000?
The Inspira HD, Model NL1000 is designed as a battery-powered device, providing a reliable and efficient power source.
What is the product code of the Inspira HD, Model NL1000?
The Inspira HD, Model NL1000 has been assigned a product code of KPS.
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: NeuroLogica - inSpira HD Community, Manuals and Specifications | MedWrench, INSPIRA HD, MODEL: NL1000 (K090811) — FDA 510(k) | Innolitics, inSPira HD SPECT - Neurologica - PDF Catalogs - MedicalExpo, NeuroLogica - inSpira HD Manuals and Documents | Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090811 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurologica Corporation
Sources (1)
- FDA 510(k) K090811 24 fields · synced Oct 6, 2026