510(k) · Cleared
Recalled · Class II · 2018True 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 Mar 3, 2017 as substantially equivalent to K142107 (Echopixel, Inc., 2015) after a 43-day review. Its family tree reaches back 8 generations to 1993. 6 later devices descend from it. It has been recalled once.
- Decided
- Mar 3, 2017
- Review
- 43 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 6 generations backK033849 Simplant SystemMaterialise NV · 2004
- 5 generations backK073468 MimicsMaterialise NV · 2008
- 4 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 3 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 2 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 1 generation backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- This deviceK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK172418 OpenSightNovarad Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · 2 generations on · 1 of its ownK213128 IntraOp VSP Software DeviceXironetic, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK243069 Lumys (V1)Intradys · 2025
- Descendant · 3 generations on · 0 of its ownK232189 OrionXRHoth Intelligence, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172418OpenSightNovarad Corporation · 2018 · cites it directly5descendants
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 2 generations on1descendant
- K213128IntraOp VSP Software DeviceXironetic, LLC · 2022 · 2 generations on1descendant
- K243069Lumys (V1)Intradys · 2025 · 3 generations on0descendants
- K232189OrionXRHoth Intelligence, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −7 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −6 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −5 | K073468 | Mimics | Materialise NV | 2008 | — |
| −4 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −3 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −2 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −1 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| 0 (this device) | K170167 | True 3D Viewer Software | Echopixel, Inc. | 2017 | — |
| +1 | K172418 | OpenSight | Novarad Corporation | 2018 | — |
| +2 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +2 | K213128 | IntraOp VSP Software Device | Xironetic, LLC | 2022 | — |
| +3 | K243069 | Lumys (V1) | Intradys | 2025 | — |
| +3 | K232189 | OrionXR | Hoth Intelligence, Inc. | 2023 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K142107 | Echo True 3D ViewerSummary page 4…Radiology A. Legally Marketed Predicate Devices The modified True 3D Viewer Software is substantially equivalent to the True 3D Viewer cleared pursuant to K142107. B. Device Description: The True 3D Viewer Software is a software application that enables a Health Care Professional (HCP) t… | 2015 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172418 | OpenSight | 2018 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2018 | Class II | Z-1785-2025 | Device Design | With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K172418 (Novarad Corporation, 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K142107.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are 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/K170167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170167: True 3D Viewer Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170167
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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