510(k) · Cleared
ClearedZedview
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lexi Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Mar 6, 2014 as substantially equivalent to K032401 (Omsbar, Ltd., 2003) and 1 other predicate after a 161-day review. Its family tree reaches back 8 generations to 1990. 10 later devices descend from it.
- Decided
- Mar 6, 2014
- Review
- 161 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K896095 (1990). 11 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 4 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 3 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 2 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 1 generation backK063327 OrthoviewMerdian Technique, Ltd. · 2006
- This deviceK133022 ZedviewLexi Co., Ltd. · 2014
- Descendant · cites it directly · 6 of its ownK171847 Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018
- Descendant · 2 generations on · 5 of its ownK183038 Corin Optimized Positioning System (OPS) PlanCorin USA · 2018
- Descendant · 2 generations on · 3 of its ownK192656 Optimized Positioning System (OPS) InsightCorin USA · 2020
- Descendant · cites it directly · 0 of its ownK211429 NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG · 2021
- Descendant · 3 generations on · 0 of its ownK210653 ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited · 2018 · cites it directly6descendants
- K183038Corin Optimized Positioning System (OPS) PlanCorin USA · 2018 · 2 generations on5descendants
- K192656Optimized Positioning System (OPS) InsightCorin USA · 2020 · 2 generations on3descendants
- K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG · 2021 · cites it directly0descendants
- K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −4 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −3 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −2 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −1 | K063327 | Orthoview | Merdian Technique, Ltd. | 2006 | — |
| 0 (this device) | K133022 | Zedview | Lexi Co., Ltd. | 2014 | — |
| +1 | K171847 | Corin Optimized Positioning System (OPS™) Plan | Corin U.S.A. Limited | 2018 | — |
| +2 | K183038 | Corin Optimized Positioning System (OPS) Plan | Corin USA | 2018 | — |
| +2 | K192656 | Optimized Positioning System (OPS) Insight | Corin USA | 2020 | — |
| +1 | K211429 | NAVIPLAN - CT Planning Software for Total Hip Replacement | Naviswiss AG | 2021 | — |
| +3 | K210653 | ONE Planner Hip | Orthosoft D/B/A Zimmer Cas | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K032401 | OrthoviewSummary page 1…Product Code LLZ Predicate Device ZedView is substantially equivalent to the Meridian Technique Ltd. OrthoviewTM (510(k) Accession Numbers: K032401 and K063327). Volume Number Page Number 8… | 2003 |
| * | K063327 | OrthoviewSummary page 1…e LLZ Predicate Device ZedView is substantially equivalent to the Meridian Technique Ltd. OrthoviewTM (510(k) Accession Numbers: K032401 and K063327). Volume Number Page Number 8… | 2006 |
What descends from it? (10)
4 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 24 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K171847 (Corin U.S.A. Limited, 2018) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K032401.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
ZedView is indicated for pre-operative planning for various surgical procedures related to hip and knee, such as artificial joint replacement (3D templating of implants) and osteotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133022: Zedview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133022
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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