510(k) · Cleared
Recalled · Class II · 2016Echo True 3D Viewer
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 Jan 21, 2015 as substantially equivalent to K123023 (Surgical Theater, LLC, 2013) after a 173-day review. Its family tree reaches back 7 generations to 1993. 27 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2015
- Review
- 173 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). 27 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK073468 MimicsMaterialise NV · 2008
- 3 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 2 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 1 generation backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- This deviceK142107 Echo True 3D ViewerEchopixel, Inc. · 2015
- Descendant · cites it directly · 18 of its ownK171356 Clarity RevealCeevra, Inc. · 2017
- Descendant · 2 generations on · 17 of its ownK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- Descendant · cites it directly · 6 of its ownK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 5 of its ownK222676 Ceevra Reveal 3Ceevra, Inc. · 2023
- Descendant · 2 generations on · 5 of its ownK172418 OpenSightNovarad Corporation · 2018
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K171356Clarity RevealCeevra, Inc. · 2017 · cites it directly18descendants
- K173274Ceevra Reveal 2.0Ceevra, Inc. · 2018 · 2 generations on17descendants
- K170167True 3D Viewer SoftwareEchopixel, Inc. · 2017 · cites it directly6descendants
- K222676Ceevra Reveal 3Ceevra, Inc. · 2023 · 3 generations on5descendants
- K172418OpenSightNovarad Corporation · 2018 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K073468 | Mimics | Materialise NV | 2008 | — |
| −3 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −2 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −1 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| 0 (this device) | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | — |
| +1 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| +2 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| +1 | K170167 | True 3D Viewer Software | Echopixel, Inc. | 2017 | 1 |
| +3 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | 2023 | — |
| +2 | K172418 | OpenSight | Novarad Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K123023 | Surgery Rehearsal PlatformSummary page 4…Radiology A. Legally Marketed Predicate Devices The t3D Viewer is substantially equivalent to the "Primary" predicate, the Surgical Theater Surgery Rehearsal Platform (K123023) with regard to both its intended use and its core technological characteristics. The Vitrea 2 v3.8 manufactured by Vital Images… | 2013 |
| † | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | 2005 |
What descends from it? (27)
See all 273 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 |
|---|---|---|---|---|
| Apr 11, 2016 | Class II | Z-1807-2025 | Software design | Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K171356 (Ceevra, Inc., 2017) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K123023.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Intended as a medical diagnostic imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as pre-operative software for simulating / evaluating surgical treatment options. The True 3D Viewer 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142107: Echo True 3D Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142107
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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