510(k) · Cleared
ClearedAccurex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybermed, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 9, 2006 as substantially equivalent to K013878 (Cybermed, Inc., 2001) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- May 9, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954678 (1996). 9 ancestors in all, the oldest K924810 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 1 generation backK053155 VimplantCybermed, Inc. · 2005
- This deviceK061126 AccurexCybermed, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK090607 Blue Sky Bio Plan, Version .38Blue Sky Bio, LLC · 2009
- Descendant · 2 generations on · 1 of its ownK190096 R2GATEMegagen Implant Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK223909 R2GATE Lite TMMegagen Implant Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −1 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| 0 (this device) | K061126 | Accurex | Cybermed, Inc. | 2006 | — |
| +1 | K090607 | Blue Sky Bio Plan, Version .38 | Blue Sky Bio, LLC | 2009 | — |
| +2 | K190096 | R2GATE | Megagen Implant Co., Ltd. | 2019 | — |
| +3 | K223909 | R2GATE Lite TM | Megagen Implant Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K013878 | Cybermed, Inc., V-WorksSummary page 1…communications system 3. Predicate Devices: Manufacturer CyberMed, Inc. Device: V-worksTm 510(k) Number: K01 3878 (Decision Date - 12107/2001) Manufacturer: CyberMed, Inc. Device: Vimplant 5… | 2001 |
| * | K053155 | VimplantSummary page 1…K01 3878 (Decision Date - 12107/2001) Manufacturer: CyberMed, Inc. Device: Vimplant 510(k) Number: K053155 (Decision Date- 11/23/2005) 4. Classifications Names & Citations: 21CFR 8B1.2050, LLZ, Picture archiving and communicat… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090607 | Blue Sky Bio Plan, Version .38 | 2009 | 2 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K090607 (Blue Sky Bio, LLC, 2009) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K013878.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Use as a software for the display and 3D visualization of dental image files from scanning devices such as CT, MRI for radiologists, dental clinicians and practitioners to acquire, process, render, review, store, print and distribute DICOM 3.0 complaint image studies, utilizing standard PC hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061126: Accurex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061126
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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