Nucleus Image Management System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171130 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 Nucleus Image Management System is a device used for the management of medical images. It is designed to support the storage, retrieval, and handling of imaging data in clinical settings.
This system is supplied as a reusable software-based system intended for use in radiology environments. It is not sterile and does not have MRI safety specifications provided in the data. The device is authorized under FDA 510(k) clearance K171130 with product code LLZ and was determined to be substantially equivalent to a predicate device.
Frequently asked questions
What is the Nucleus Image Management System used for?
The Nucleus Image Management System is used for the management of medical images, specifically designed to support the storage, retrieval, and handling of imaging data in clinical radiology settings.
Is the Nucleus Image Management System sterile or single-use?
The Nucleus Image Management System is not sterile and is supplied as a reusable software-based system, meaning it is intended for repeated use in radiology environments rather than single-use disposal.
How is the Nucleus Image Management System supplied and what environments is it intended for?
The device is supplied as a reusable software-based system and is intended for use in radiology environments to manage medical imaging data through storage, retrieval, and handling functions.
What regulatory authorization does the Nucleus Image Management System have?
The Nucleus Image Management System is authorized under FDA 510(k) clearance K171130, with product code LLZ, and was determined to be substantially equivalent to a predicate device.
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 | K171130 | Class II | Active |
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Manufacturer
- Manufacturer
- Nucleushealth, LLC
Sources (1)
- FDA 510(k) K171130 24 fields · synced Sep 23, 2026