510(k) · Cleared
Recalled · Class II · 2023Nucleus.io
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 Dec 4, 2020 as substantially equivalent to K082269 (Visage Imaging, Inc., 2008) after a 30-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Dec 4, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945188 (1995). 8 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 5 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 4 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 3 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 2 generations backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- 1 generation backK082269 Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008
- This deviceK203249 Nucleus.ioNucleushealth, LLC · 2020
- Descendant · cites it directly · 3 of its ownK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK254237 Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026
- Descendant · 2 generations on · 0 of its ownK241546 aiCockpit AI ViewerFovia, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK242362 Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024
- Descendant · cites it directly · 0 of its ownK241981 Change Healthcare Stratus Imaging PACSChange Healthcare Canada Company · 2024
Most influential descendants
Showing 5 of 5 · See all- K222476OmegaAI Image ViewerRamsoft, Inc. · 2022 · cites it directly3descendants
- K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026 · 2 generations on0descendants
- K241546aiCockpit AI ViewerFovia, Inc. · 2025 · 2 generations on0descendants
- K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024 · 2 generations on0descendants
- K241981Change Healthcare Stratus Imaging PACSChange Healthcare Canada Company · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −5 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −4 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −3 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −2 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| −1 | K082269 | Visage Pacs, Version 6.0/CS 3.1 | Visage Imaging, Inc. | 2008 | — |
| 0 (this device) | K203249 | Nucleus.io | Nucleushealth, LLC | 2020 | — |
| +1 | K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022 | — |
| +2 | K254237 | Cci Pacs Viewer (Pacs-US-001) | CliniComp, Intl. | 2026 | — |
| +2 | K241546 | aiCockpit AI Viewer | Fovia, Inc. | 2025 | — |
| +2 | K242362 | Lightning Viewer | Nexsys Electronics Inc. Dba Medweb | 2024 | — |
| +1 | K241981 | Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082269 | Visage Pacs, Version 6.0/CS 3.1Summary page 5…device under 510(K) K171130. 1.5 Predicate Device Identification Proprietary Name(s): Visage PACS/CS 510(k) File: K082269 Classification Name: Picture Archiving & Communications System (PACS) No reference devices were used in this… | 2008 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2023 | Class II | Z-0551-2024 | Software design | Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K222476 (Ramsoft, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K082269.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
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…
Read the full statement (381 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203249: Nucleus.io.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203249
Report an extraction error
Are you the manufacturer?
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