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 Dec 16, 2011 as substantially equivalent to K070464 (Cybermed, Inc., 2007) and 3 other predicates after a 15-day review. Its family tree reaches back 6 generations to 1996. 9 later devices descend from it.
- Decided
- Dec 16, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K954874 (1996). 38 ancestors in all, the oldest K871859 (1987). 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 4 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 3 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 2 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 1 generation backK061370 Cardiq FusionGE Healthcare · 2006
- This deviceK113543 ONDEMAND3DCybermed, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK131616 EZ3D-I, E3Ewoosoft Co., Ltd. · 2013
- Descendant · 2 generations on · 3 of its ownK150761 Ez3D-i/E3Ewoosoft Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK161246 Ez3D-i / E3Ewoosoft Co., Ltd. · 2016
- Descendant · 4 generations on · 1 of its ownK163539 Ez3D-i / E3Ewoosoft Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK152746 Ez3D PlusEwoosoft Co., Ltd. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131616EZ3D-I, E3Ewoosoft Co., Ltd. · 2013 · cites it directly4descendants
- K150761Ez3D-i/E3Ewoosoft Co., Ltd. · 2015 · 2 generations on3descendants
- K161246Ez3D-i / E3Ewoosoft Co., Ltd. · 2016 · 3 generations on2descendants
- K163539Ez3D-i / E3Ewoosoft Co., Ltd. · 2016 · 4 generations on1descendant
- K152746Ez3D PlusEwoosoft Co., Ltd. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −5 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −4 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −3 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −2 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −1 | K061370 | Cardiq Fusion | GE Healthcare | 2006 | — |
| 0 (this device) | K113543 | ONDEMAND3D | Cybermed, Inc. | 2011 | — |
| +1 | K131616 | EZ3D-I, E3 | Ewoosoft Co., Ltd. | 2013 | — |
| +2 | K150761 | Ez3D-i/E3 | Ewoosoft Co., Ltd. | 2015 | — |
| +3 | K161246 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016 | — |
| +4 | K163539 | Ez3D-i / E3 | Ewoosoft Co., Ltd. | 2016 | — |
| +1 | K152746 | Ez3D Plus | Ewoosoft Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K070464 | ONDEMAND3DSummary page 1…er: :CyberMed, Inc. Device: :OnDemand3D TM 510(k) Number: :K070464 (Decision Date - 03/16/2007) Manufacturer: :Materialise, N.V.… | 2007 |
| * | K033849 | Simplant SystemSummary page 1…:Materialise, N.V. Device: :SimPlant System 510(k) Number: :K033849 (Decision Date - 05/25/2004) Manufacturer: :Anatomage, Inc.… | 2004 |
| * | K070803 | InvivodentalSummary page 1…rer: :Anatomage, Inc. Device: :Invivo Dental 510(k) Number: :K070803 (Decision Date - 04/06/2007) Manufacturer: :GE Medical systems SCS… | 2007 |
| * | K061370 | Cardiq FusionSummary page 2…1537 - dbliU1 CyberMed, Inc. Device: :CardIQ Fusion 510(k) Number: :K061370 (Decision Date - 05/30/2006) 4. Classifications Names & Citations : 21CFR 892.2050, LLZ, Picture archiving and communicat… | 2006 |
What descends from it? (9)
3 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 15 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K131616 (Ewoosoft Co., Ltd., 2013) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K070464.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 OnDemand3D G2 is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 20 analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. It also provides the following functions as shown below. 1) Functions for implant surgery planning and fabricating a surgical guide according to the plan 2) Functions to combine and show the image…
Read the full statement (123 words)
The OnDemand3D G2 is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 20 analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
It also provides the following functions as shown below.
1) Functions for implant surgery planning and fabricating a surgical guide according to the plan
2) Functions to combine and show the image data from different modalities such as CT, MRI and PET in one window at the same time
3) Functions to create orthodontic analysis using 3D volume data
4) Functions to sort and save DICOM files, Project Files and 2D image files from different modality [Panorama, Cephalometric, intraoral] under a single patient name
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113543: ONDEMAND3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113543
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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