510(k) · Cleared
ClearedONDEMAND3D
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 Mar 16, 2007 as substantially equivalent to K032760 (Tis, Inc., 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1996. 14 later devices descend from it.
- Decided
- Mar 16, 2007
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K954678 (1996). 10 ancestors in all, the oldest K924810 (1993). 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- This deviceK070464 ONDEMAND3DCybermed, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK113543 ONDEMAND3DCybermed, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK131616 EZ3D-I, E3Ewoosoft Co., Ltd. · 2013
- Descendant · 3 generations on · 3 of its ownK150761 Ez3D-i/E3Ewoosoft Co., Ltd. · 2015
- Descendant · 4 generations on · 2 of its ownK161246 Ez3D-i / E3Ewoosoft Co., Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK102684 Xelis DentalInfinitt Co., Ltd. · 2010
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K113543ONDEMAND3DCybermed, Inc. · 2011 · cites it directly9descendants
- K131616EZ3D-I, E3Ewoosoft Co., Ltd. · 2013 · 2 generations on4descendants
- K150761Ez3D-i/E3Ewoosoft Co., Ltd. · 2015 · 3 generations on3descendants
- K161246Ez3D-i / E3Ewoosoft Co., Ltd. · 2016 · 4 generations on2descendants
- K102684Xelis DentalInfinitt Co., Ltd. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| 0 (this device) | K070464 | ONDEMAND3D | Cybermed, Inc. | 2007 | — |
| +1 | K113543 | ONDEMAND3D | Cybermed, Inc. | 2011 | — |
| +2 | K131616 | EZ3D-I, E3 | Ewoosoft Co., Ltd. | 2013 | — |
| +3 | K150761 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2015 | — |
| +4 | K161246 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016 | — |
| +1 | K102684 | Xelis Dental | Infinitt Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K032760 | Apax Pacs SystemSummary page 1…Predicate Devices Manufacturer: :TIS Inc. Device: :APAXTM 510(k) Number: :K032760 (Decision Date - 09/17/2003) Manufacturer: MATERIALISE N.V. Device:… | 2003 |
| * | K033849 | Simplant SystemSummary page 1…Manufacturer: MATERIALISE N.V. Device: SimPlant System 510(k) Number: :K033849 (Decision Date - 05/25/2004) Manufacturer :MEVISYS, Go., Ltd. Device… | 2004 |
| * | K022692 | Voxelplus PacsSummary page 1…Manufacturer :MEVISYS, Go., Ltd. Device :VOXELPLUS TM PACS 510(k) Number K022692 (Decision Date - 10/1 1/2002) #504 SJ Technoville, Gasan-dong 60-19, Geumcheon-gu, Seoul, 13a 6 =… | 2002 |
What descends from it? (14)
See all 143 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 11 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K113543 (Cybermed, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K032760.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 OnDemand3DTM is intended for use as a software package which
loads DICOM images from CT, MR, X-Ray, stores those and provides 3D
visualization and 2D analysis, various MPR (Multi-Planar Reconstruction)
functions for further rapid and precise diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070464: ONDEMAND3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070464
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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