510(k) · Cleared
ClearedTABLE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anatomage, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 7, 2014 as substantially equivalent to K123519 (Anatomage, Inc., 2013) after a 52-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 52 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 15 ancestors in all, the oldest K924810 (1993). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 3 generations backK053155 VimplantCybermed, Inc. · 2005
- 2 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 1 generation backK123519 Invivo DentalAnatomage, Inc. · 2013
- This deviceK140093 TABLEAnatomage, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK142048 Emprint Procedure Planning ApplicationCovidien, LLC · 2014
- Descendant · 2 generations on · 2 of its ownK180192 Emprint Ablation Visualization ApplicationCovidien, LLC · 2018
- Descendant · 3 generations on · 1 of its ownK192038 Emprint Visualization ApplicationCovidien, LLC · 2019
- Descendant · 4 generations on · 0 of its ownK252947 HistoSonics® Planning ToolHistoSonics, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K142048Emprint Procedure Planning ApplicationCovidien, LLC · 2014 · cites it directly3descendants
- K180192Emprint Ablation Visualization ApplicationCovidien, LLC · 2018 · 2 generations on2descendants
- K192038Emprint Visualization ApplicationCovidien, LLC · 2019 · 3 generations on1descendant
- K252947HistoSonics® Planning ToolHistoSonics, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −3 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −2 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −1 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| 0 (this device) | K140093 | TABLE | Anatomage, Inc. | 2014 | — |
| +1 | K142048 | Emprint Procedure Planning Application | Covidien, LLC | 2014 | — |
| +2 | K180192 | Emprint Ablation Visualization Application | Covidien, LLC | 2018 | — |
| +3 | K192038 | Emprint Visualization Application | Covidien, LLC | 2019 | — |
| +4 | K252947 | HistoSonics® Planning Tool | HistoSonics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K123519 | Invivo DentalSummary page 2…PC hardware. This device is not indicated for mammography use. Equivalent Devices K 1235 19 Anatomage, InVivoDental Technological Characteristic Table and the predicate device are standalone software. These… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142048 | Emprint Procedure Planning Application | 2014 | 3 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K142048 (Covidien, LLC, 2014) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K123519.
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?
Table is a software application used for the display and 3D visualization of medical image files from scanning devices such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process. render, review, and assist in diagnosis. utilizing standard PC hardware.
This device is not indicated for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140093: TABLE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140093
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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