510(k) · Cleared
ClearedeUnity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Client Outlook, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 6, 2018 as substantially equivalent to K161515 (Client Outlook, Inc., 2016) after a 173-day review. Its family tree reaches back 1 generation to 2016. 5 later devices descend from it.
- Decided
- Feb 6, 2018
- Review
- 173 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K161515 (2016). 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK161515 eUnityClient Outlook, Inc. · 2016
- This deviceK172490 eUnityClient Outlook, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK223425 MD.ai ViewerMdai, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK251881 HippoMind (v1.0)Hippoclinic · 2025
- Descendant · cites it directly · 0 of its ownK240724 SynthVISION 1.0.0Synthesis Health Intelligence, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233331 MediOMxPmx, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK203058 CloudVueInternational Medical Solutions, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K223425MD.ai ViewerMdai, Inc. · 2023 · cites it directly1descendant
- K251881HippoMind (v1.0)Hippoclinic · 2025 · cites it directly0descendants
- K240724SynthVISION 1.0.0Synthesis Health Intelligence, Inc. · 2024 · cites it directly0descendants
- K233331MediOMxPmx, Inc. · 2024 · 2 generations on0descendants
- K203058CloudVueInternational Medical Solutions, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K161515 | eUnity | Client Outlook, Inc. | 2016 | — |
| 0 (this device) | K172490 | eUnity | Client Outlook, Inc. | 2018 | — |
| +1 | K223425 | MD.ai Viewer | Mdai, Inc. | 2023 | — |
| +1 | K251881 | HippoMind (v1.0) | Hippoclinic | 2025 | — |
| +1 | K240724 | SynthVISION 1.0.0 | Synthesis Health Intelligence, Inc. | 2024 | — |
| +2 | K233331 | MediOMx | Pmx, Inc. | 2024 | — |
| +1 | K203058 | CloudVue | International Medical Solutions, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K161515 | eUnitySummary page 4…are which is substantially equivalent to the FDA cleared previous version of eUnity Software (k161515) Submitter: Client Outlook Inc. 103 Bauer Place, Suite #3… | 2016 |
| † | K161130 | ResolutionMD | 2016 |
| † | K133508 | Resolutionmd Mobile | 2014 |
| † | K151774 | CARESTREAM Vue Motion | 2015 |
What descends from it? (5)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K223425 (Mdai, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
eUnity is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data. eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup. eUnity provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and…
Read the full statement (143 words)
eUnity is a software application that displays medical image data and associated clinical reports to aid in diagnosis for healthcare professionals. It performs operations relating to the transfer, storage, display, and measurement of image data.
eUnity allows users to perform image manipulations, including window/level, rotation, measurement and markup.
eUnity provides 2D display, Multi-Planar Reformatting and 3D visualization of medical image data, and mobile access to images.
eUnity displays both lossless and lossy compressed images. For lossy images, the medical professional user must determine if the level of loss is acceptable for their purposes. Display monitors or mobile devices used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. For mobile diagnostic usage when a full workstation is not available.
Mobile usage for mammography is for reference and referral only.
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/K172490 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172490: eUnity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172490
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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