510(k) · Cleared
ClearedEmprint Visualization Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 2, 2019 as substantially equivalent to K180192 (Covidien, LLC, 2018) after a 125-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.
- Decided
- Dec 2, 2019
- Review
- 125 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954678 (1996). 22 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations between
- 3 generations backK140093 TABLEAnatomage, Inc. · 2014
- 2 generations backK142048 Emprint Procedure Planning ApplicationCovidien, LLC · 2014
- 1 generation backK180192 Emprint Ablation Visualization ApplicationCovidien, LLC · 2018
- This deviceK192038 Emprint Visualization ApplicationCovidien, LLC · 2019
- Descendant · cites it directly · 0 of its ownK252947 HistoSonics® Planning ToolHistoSonics, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 8 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 7 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 6 generations backK053155 VimplantCybermed, Inc. · 2005
- 5 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 4 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 3 generations backK140093 TABLEAnatomage, Inc. · 2014
- 2 generations backK142048 Emprint Procedure Planning ApplicationCovidien, LLC · 2014
- 1 generation backK180192 Emprint Ablation Visualization ApplicationCovidien, LLC · 2018
- This deviceK192038 Emprint Visualization ApplicationCovidien, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K252947HistoSonics® Planning ToolHistoSonics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −9 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −8 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −7 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −6 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −5 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −4 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −3 | K140093 | TABLE | Anatomage, Inc. | 2014 | — |
| −2 | K142048 | Emprint Procedure Planning Application | Covidien, LLC | 2014 | — |
| −1 | K180192 | Emprint Ablation Visualization Application | Covidien, LLC | 2018 | — |
| 0 (this device) | K192038 | Emprint Visualization Application | Covidien, LLC | 2019 | — |
| +1 | K252947 | HistoSonics® Planning Tool | HistoSonics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K180192 | Emprint Ablation Visualization ApplicationSummary page 4…ailable predicate device: Device Trade Name: Emprint™ Ablation Visualization Application Device Common Name: DICOM Viewer 510(k) Numbers: K180192 Manufacturer: Covidien llc Device Description The Emprint™ Visualization Application is a software product that a… | 2018 |
| † | K133821 | Emprint Ablation System | 2014 |
| † | K171358 | Emprint SX Ablation Platform and Accessories | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252947 | HistoSonics® Planning Tool | 2026 | 0 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K252947 (HistoSonics, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Emprint™ Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems. The software is not intended for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192038 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192038: Emprint Visualization Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192038
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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