510(k) · Cleared
ClearedTrue 3D Viewer Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echopixel, Inc. · LLZ System, Image Processing, Radiological
Cleared on Dec 27, 2019 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 27, 2019
- Review
- 44 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK193149 True 3D Viewer SoftwareEchopixel, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK210072 HOLOSCOPE-iReal View Imaging, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK223125 XR90 (XR90-Sys)Mediview Xr, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · 3 generations on · 0 of its ownK253486 SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK243069 Lumys (V1)Intradys · 2025
Most influential descendants
Showing 5 of 5 · See all- K210072HOLOSCOPE-iReal View Imaging, Ltd. · 2021 · cites it directly4descendants
- K223125XR90 (XR90-Sys)Mediview Xr, Inc. · 2023 · 2 generations on1descendant
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 2 generations on1descendant
- K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026 · 3 generations on0descendants
- K243069Lumys (V1)Intradys · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K193149 | True 3D Viewer Software | Echopixel, Inc. | 2019 | — |
| +1 | K210072 | HOLOSCOPE-i | Real View Imaging, Ltd. | 2021 | — |
| +2 | K223125 | XR90 (XR90-Sys) | Mediview Xr, Inc. | 2023 | — |
| +2 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +3 | K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026 | — |
| +3 | K243069 | Lumys (V1) | Intradys | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210072 | HOLOSCOPE-i | 2021 | 4 |
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?
- Of its descendants, K210072 (Real View Imaging, Ltd., 2021) has gone furthest, with 4 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. 2019, 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 True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI, XA and Ultrasound sources. It is also intended as software which provides visual information to be used by the health care professional for analysis of surgical options, and the intraoperative display of the mentioned images. The True 3D Viewer software is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K193149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193149: True 3D Viewer Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193149
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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