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510(k) Data Aggregation
K Number
K203249Device Name
Nucleus.io
Manufacturer
NucleusHealth, LLC
Date Cleared
2020-12-04
(30 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NucleusHealth, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
Nucleus.io is a PACS which, when integrated with standard off-the-shelf hardware/software, acts similarly to its predicate device and other industry standard PACS systems. The Nucleus System has the following primary features and functions: Zero-footprint HTML5 medical image acceptance (upload) and transfer of medical images between facilities. Easy, real-time access to images for all participants in the healthcare process, including radiologists, imaging technicians, workflow coordinators, physicians, nurses, and other patient care facilitators. High-speed, zero-footprint diagnostic review of medical images using industry-standard tools for manipulation, annotation, measurement, and comparison. Simultaneous information review with multiple parties, including radiologists and coordinators. Sharing of medical images between healthcare providers, facilities, and patients. Encrypted transmission of medical images through secured wired and wireless networks. Encrypted storage of medical images. Organization and matching of multiple medical images based on patient name, medical record number, facility, etc. Quality assurance review of studies by coordinators and preparation of information for study interpretation by radiologists. Notification of care coordinators that studies need to be transferred to client systems. HIPAA-compliant data management and LDAP security integration with external systems Management of users, roles, permissions, and organization accounts Configuration of image acceptance (upload) and transfer settings. The Nucleus.io System consists of the following primary components: Nucleus.io Image Exchange (iX)™ - Exam acceptance (upload), transfer, sharing, and management. Nucleus.io Viewer (dX)™ - Zero-footprint streaming viewer suitable for diagnostic image review of all modalities. Nucleus.io Infinite Store (iS)™ (formerly Image Store) - Image storage and archiving. Nucleus.io PACS™ - Radiology workflow and worklist features. Nucleus PaaS - Vendor-neutral Class I platform that can be incorporated as a component of other devices.
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K Number
K171130Device Name
Nucleus Image Management System
Manufacturer
NucleusHealth, LLC
Date Cleared
2017-05-04
(17 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NucleusHealth, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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 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.
Device Description
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 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 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.
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