510(k) · Cleared
ClearedNucleus Image Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucleushealth, LLC · LLZ System, Image Processing, Radiological
Cleared on May 4, 2017 as substantially equivalent to K092134 (Statrad, LLC, 2009) after a 17-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- May 4, 2017
- Review
- 17 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945188 (1995). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 6 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 5 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 4 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 3 generations backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- 2 generations backK082269 Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008
- 1 generation backK092134 Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC · 2009
- This deviceK171130 Nucleus Image Management SystemNucleushealth, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −6 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −5 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −4 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −3 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| −2 | K082269 | Visage Pacs, Version 6.0/CS 3.1 | Visage Imaging, Inc. | 2008 | — |
| −1 | K092134 | Stat Pacs Picture Archiving & Communication System (Pacs) | Statrad, LLC | 2009 | — |
| 0 (this device) | K171130 | Nucleus Image Management System | Nucleushealth, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092134 | Stat Pacs Picture Archiving & Communication System (Pacs)Summary page 4…892.2050 Product Code: LLZ Regulatory Class: Class II Device Panel: Radiology Predicate device(s): StatRad, LLC StatPacs K092134 III Device Description/Intended use: Nucleus Image Management System 510k… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (313 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171130: Nucleus Image Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171130
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026