510(k) · Cleared
ClearedVisible Patient Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visible Patient, Sas · LLZ System, Image Processing, Radiological
Cleared on Nov 5, 2021 as substantially equivalent to K151988 (Visible Patient, Sas, 2015) after a 56-day review. Its family tree reaches back 14 generations to 1991. 3 later devices descend from it.
- Decided
- Nov 5, 2021
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K913770 (1991). 136 ancestors in all, the oldest K871859 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- 2 generations backK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- 1 generation backK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- This deviceK212896 Visible Patient SuiteVisible Patient, Sas · 2021
- Descendant · cites it directly · 1 of its ownK250237 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK260973 InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK233457 RUSHutom, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 12 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 11 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 10 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 9 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 8 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 7 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 6 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 5 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 4 generations backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- 3 generations backK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
- 2 generations backK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- 1 generation backK151988 Visible Patient SuiteVisible Patient, Sas · 2015
- This deviceK212896 Visible Patient SuiteVisible Patient, Sas · 2021
Most influential descendants
Showing 3 of 3 · See all- K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2025 · cites it directly1descendant
- K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K233457RUSHutom, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −12 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −11 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −10 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −9 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −8 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −7 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −6 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −5 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −4 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| −3 | K121213 | Vitreaadvanced | Vital Images, Inc. | 2012 | 1 |
| −2 | K142521 | Synapse 3D Liver and Kidney Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| −1 | K151988 | Visible Patient Suite | Visible Patient, Sas | 2015 | — |
| 0 (this device) | K212896 | Visible Patient Suite | Visible Patient, Sas | 2021 | — |
| +1 | K250237 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2025 | — |
| +2 | K260973 | InferOperate Suite | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026 | — |
| +1 | K233457 | RUS | Hutom, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 9 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 15 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K151988 | Visible Patient SuiteSummary page 4…and Processing System Regulatory Class: Class II Regulation number: 892.2050 Product Code: LLZ Predicate Device Visible Patient Suite, Visible Patient, SAS, K151988 Indications For Use Visible Patient Suite is medical imaging software that is intended to provide trained medical… | 2015 |
What descends from it? (3)
2 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 30 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 32 of the 136 ancestors have a recall of any class.
- Of its descendants, K250237 (Beijing Infervision Healthcare Medical Technology Co., Ltd., 2025) has gone furthest, with 1 descendant 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. 2021, 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?
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR. This product is not intended for use with or for the primary diagnostic interpretation of Mammography…
Read the full statement (207 words)
Visible Patient Suite is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, reporting, and treatment planning for both pediatric and adult patients. Visible Patient Suite accepts DICOM compliant medical images acquired from a variety of imaging devices, including CT, MR.
This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.
The software provides several categories of tools. It includes basic imaging tools for general images, including 2D viewing, volume rendering and 3D volume viewing, orthogonal Multi-Planar Reconstructions (MPR), image fusion, surface rendering, measurements, reporting, storing, general image management and administration tools, etc.
It includes a basic image processing workflow and a custom UI to segment anatomical structures, which are visible in the image data (bones, organs, vascular/airway structures, etc.), including interactive segmentation tools, basic image filters, etc.
It also includes detection and labeling tools of organ segments (liver, lungs and kidneys), including path definition through vascular/airway, approximation of vascular/airway territories from tubular structures and interactive labeling.
The software is designed to be used by trained professionals (including physicians, surgeons and technicians) and is intended to assist the clinician who is solely responsible for making all final patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212896: Visible Patient Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212896
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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