# K203249: Nucleus.io

- Pathway: 510(k) (Traditional)
- Applicant: Nucleushealth, LLC
- Decided: Dec 4, 2020 after 30 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945188 (1995). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082269: Visage Pacs, Version 6.0/CS 3.1, Visage Imaging, Inc. (2008) Summary page 5.

## Most influential descendants
- K222476: OmegaAI Image Viewer (2022), 3 descendants of its own
- K254237: Cci Pacs Viewer (Pacs-US-001) (2026), 0 descendants of its own
- K241546: aiCockpit AI Viewer (2025), 0 descendants of its own
- K242362: Lightning Viewer (2024), 0 descendants of its own
- K241981: Change Healthcare Stratus Imaging PACS (2024), 0 descendants of its own

## Recalls of this device
- Nov 1, 2023 · Class II · Z-0551-2024: Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.

## Indications for use
Nucleus.io is a software-based image management solution and PACS to be used by radiologists, other medical personnel and patients. Nucleus.io 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 Nucleus.io are web-based and can operate on off-the-shelf hardware, as needed. Nucleus.io consists of the following primary components: Nucleus.io Viewer (dX) with image streaming technology for use by medical professionals for diagnostic and clinical image review-Nucleus.io Image Exchange (iX) for image acceptance, transfer, and sharing with hospitals/clinics as well as between facilities , Nucleus.io Infinite Store (iS) for secure cloud-based image storage and management through HIPAA compliant encryption-Nucleus.io PACS for radiology workflow and worklist features when used in conjunction with Nucleus.io dX and, optionally , Nucleus.io iS-and Nucleus.io PaaS, which provides a vendor-neutral Class I platform that can be incorporated as a component of other devices. Nucleus.io 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. Nucleus.io 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 (PET), and X-Ray Angiography (XA). When appropriate, Nucleus.io provides and installs software and, optionally, off-the-shelf 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. Nucleus.io can be used as a full-featured PACS or as an independent viewer in clinical settings. Although the web and thin client technologies allow the software to be run on a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state of- the-art diagnostic requirements and currently valid laws. Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography. Not for diagnostic use on mobile devices.

Source page: https://510kreport.com/device/K203249
Methodology: https://510kreport.com/methodology