510(k) · Cleared
ClearedZeeroMED View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O3 Enterprise Srl · LLZ System, Image Processing, Radiological
Cleared on May 5, 2020 as substantially equivalent to K162011 (Softneta Uab, 2016) after a 63-day review. Its family tree reaches back 1 generation to 2016. 6 later devices descend from it.
- Decided
- May 5, 2020
- Review
- 63 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K162011 (2016). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK162011 MedDreamSoftneta Uab · 2016
- This deviceK200546 ZeeroMED ViewO3 Enterprise Srl · 2020
- Descendant · cites it directly · 2 of its ownK233226 FlexView Diagnostic (v1.1.20)Radical Imaging, LLC · 2024
- Descendant · cites it directly · 1 of its ownK221065 MediLabSigma Scientific Services, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK262449 AdvaViewAdvahealth Solutions, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK253784 3DICOM MD CloudSingular Health Pty, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK223048 Medisystem PacsMedilab Manutencao E Sitemas Ltda · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K233226FlexView Diagnostic (v1.1.20)Radical Imaging, LLC · 2024 · cites it directly2descendants
- K221065MediLabSigma Scientific Services, LLC · 2022 · cites it directly1descendant
- K262449AdvaViewAdvahealth Solutions, LLC · 2026 · 2 generations on0descendants
- K2537843DICOM MD CloudSingular Health Pty, Ltd. · 2026 · 2 generations on0descendants
- K223048Medisystem PacsMedilab Manutencao E Sitemas Ltda · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K162011 | MedDream | Softneta Uab | 2016 | — |
| 0 (this device) | K200546 | ZeeroMED View | O3 Enterprise Srl | 2020 | — |
| +1 | K233226 | FlexView Diagnostic (v1.1.20) | Radical Imaging, LLC | 2024 | — |
| +1 | K221065 | MediLab | Sigma Scientific Services, LLC | 2022 | — |
| +2 | K262449 | AdvaView | Advahealth Solutions, LLC | 2026 | — |
| +2 | K253784 | 3DICOM MD Cloud | Singular Health Pty, Ltd. | 2026 | — |
| +2 | K223048 | Medisystem Pacs | Medilab Manutencao E Sitemas Ltda | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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 21.6 · 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 |
|---|---|---|---|
| * | K162011 | MedDreamSummary page 6…area measurements. Predicate Devices The O3 ENTERPRISE system is equivalent to the MEDDREAM Picture Archiving and Communications system by Softneta UAB cleared under K162011. Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]: ZeeroMED View is comparable with and substantially equivalent to… | 2016 |
What descends from it? (6)
3 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, K233226 (Radical Imaging, LLC, 2024) has gone furthest, with 2 descendants 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. 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?
ZeeroMED View software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. ZeeroMED View displays and manages diagnostic quality DICOM images. ZeeroMED View is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. ZeeroMED View is not intended for diagnostic use on mobile devices.
Contraindications: The ZeeroMED View is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200546 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200546: ZeeroMED View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200546
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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