510(k) · Cleared
ClearedFlexView Diagnostic (v1.1.20)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radical Imaging, LLC · LLZ System, Image Processing, Radiological
Cleared on Jan 17, 2024 as substantially equivalent to K200546 (O3 Enterprise Srl, 2020) after a 111-day review. Its family tree reaches back 2 generations to 2016. 2 later devices descend from it.
- Decided
- Jan 17, 2024
- Review
- 111 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K162011 (2016). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK162011 MedDreamSoftneta Uab · 2016
- 1 generation backK200546 ZeeroMED ViewO3 Enterprise Srl · 2020
- This deviceK233226 FlexView Diagnostic (v1.1.20)Radical Imaging, LLC · 2024
- Descendant · cites it directly · 0 of its ownK262449 AdvaViewAdvahealth Solutions, LLC · 2026
- Descendant · cites it directly · 0 of its ownK253784 3DICOM MD CloudSingular Health Pty, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K162011 | MedDream | Softneta Uab | 2016 | — |
| −1 | K200546 | ZeeroMED View | O3 Enterprise Srl | 2020 | — |
| 0 (this device) | K233226 | FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC | 2024 | — |
| +1 | K262449 | AdvaView | Advahealth Solutions, LLC | 2026 | — |
| +1 | K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K200546 | ZeeroMED ViewSummary page 4…Class II Panel Radiology 3. PREDICATE DEVICE INFORMATION Predicate Device Name ZeeroMED View Predicate Device 510(k) Number K200546 Product Code LLZ Radical Imaging… | 2020 |
What descends from it? (2)
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)
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 8 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K262449 (Advahealth Solutions, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K200546.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
FlexView Diagnostic is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data (e.g., video information) with associated reports and information. FlexView Diagnostic enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data. FlexView Diagnostic allows qualified users to perform simple and complex image manipulations (including window/level, markups, 3D visualization) and measurements.
Not intended for primary diagnosis of mammographic images.
Not intended for diagnostic use on mobile devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233226: FlexView Diagnostic (v1.1.20).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233226
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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