Nucleus Image Management System Software Radiology

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK171130	Date4 May 2017Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K171130

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K171130
FDA product code: LLZ

Device class: Class II
Regulation: 21 CFR Part 892.2050
Advisory committee: Radiology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Stat Pacs Picture Archiving & Communication System (Pacs) K092134 15 Sep 2009 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K171130

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K171130
		UDI-DI	Size and differences
Nucleus.io 24 Change Healthcare Canada Company	24	17540262140019	—	No longer on the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Nucleushealth, LLC

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Nucleus.io Open recall

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