# K171130: Nucleus Image Management System

- Pathway: 510(k) (Traditional)
- Applicant: Nucleushealth, LLC
- Decided: May 4, 2017 after 17 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945188 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092134: Stat Pacs Picture Archiving & Communication System (Pacs), Statrad, LLC (2009) Summary page 4.

## Indications for use
The Nucleus Image Management System (Nucleus IMS) is a software based PACS, to be used by radiologists and other medical personnel. The Nucleus IMS is comprised of software modules that provide image receipt, diagnostic viewing, storage, distribution, enhancement, sharing, manipulation, and networking of medical 2D/3D images at distributed locations. All modules of the Nucleus IMS are web-based and can operate on off-the-shelf hardware, as needed. The Nucleus IMS consists of the following primary components: Nucleus Viewer with image streaming technology for use by medical professionals for diagnostic and clinical image review—Nucleus Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities—and Nucleus Image Store for secure cloud based image storage and management through HIPAA compliant encryption. Nucleus iX integrates with the Nucleus Viewer and Nucleus Image Store. Nucleus.io, a web based class I PaaS device, provides the basis for the system and for vendor neutral applications. The Nucleus IMS interfaces with health information systems (HIS) using industry-standard image transfer and data exchange protocols—such as DICOM, HL7, and HTML—through web-based networked gateways and local and wide area networks. The Nucleus IMS is compatible with modalities including: Computed Tomography (CT), Magnetic Resonance Imaging (MR), Ultrasound (US), Computed Radiography (CR), Digital Radiography (DX), Nuclear Medicine (NM), Positron Emission Tomography (PT), and X-Ray Angiography (XA). When appropriate, the Nucleus IMS provides and installs software and, optionally, server hardware at client facilities to facilitate secure, web-based connections for image transmission to and from hospital central servers via the Internet. Additionally, industry standard HTTPS, VPNs, and other encryption methodologies are utilized to allow for optimal, secure, rapid streaming of images. Lossless image compression and encryption adhere to standard industry protocols. The Nucleus IMS can be used as a full featured PACS or as an independent viewer in clinical settings. Nucleus Image Management System is not intended for display of mammography imaging for diagnosis.

Source page: https://510kreport.com/device/K171130
Methodology: https://510kreport.com/methodology