510(k) · Cleared
ClearedTumorSight Viz
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SimBioSys, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jul 8, 2025 as substantially equivalent to K243189 (SimBioSys, Inc., 2024) after a 29-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Jul 8, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913770 (1991). 77 ancestors in all, the oldest K896095 (1990). No later device cites it as a predicate yet.
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations between
- 3 generations backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- 2 generations backK231130 TumorSight VizSimBioSys, Inc. · 2023
- 1 generation backK243189 TumorSight VizSimBioSys, Inc. · 2024
- This deviceK251766 TumorSight VizSimBioSys, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 12 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 11 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 10 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 9 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 8 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 7 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 6 generations backK052963 Mediq Version 1.0Clario Medical Imaging, Inc. · 2005
- 5 generations backK080196 Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
- 4 generations backK081556 Cadstream, Version 5.0Confirma, Inc. · 2009
- 3 generations backK092954 Cadstream Version 5Confirma, Inc. · 2009 · Recalled
- 2 generations backK231130 TumorSight VizSimBioSys, Inc. · 2023
- 1 generation backK243189 TumorSight VizSimBioSys, Inc. · 2024
- This deviceK251766 TumorSight VizSimBioSys, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −12 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −11 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −10 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −9 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −8 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −7 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −6 | K052963 | Mediq Version 1.0 | Clario Medical Imaging, Inc. | 2005 | — |
| −5 | K080196 | Z3D Contrast Acuity | Clario Medical Imaging, Inc. | 2008 | — |
| −4 | K081556 | Cadstream, Version 5.0 | Confirma, Inc. | 2009 | — |
| −3 | K092954 | Cadstream Version 5 | Confirma, Inc. | 2009 | 3 |
| −2 | K231130 | TumorSight Viz | SimBioSys, Inc. | 2023 | — |
| −1 | K243189 | TumorSight Viz | SimBioSys, Inc. | 2024 | — |
| 0 (this device) | K251766 | TumorSight Viz | SimBioSys, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 |
|---|---|---|---|
| * | K243189 | TumorSight VizSummary page 5…cal Regulation Number: 892.2050 Product Code: QIH Committee/Panel: Radiology Device Class: II Identification of the Legally Marketed Predicate Device Predicate #: K243189 Predicate Trade Name: TumorSight Viz Product Code: QIH Device Description TumorSight Viz is an image processing system des… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 18 of the 77 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
TumorSight Viz is intended to be used in the visualization and analysis of breast magnetic resonance imaging (MRI) studies for patients with biopsy proven early-stage or locally advanced breast cancer. TumorSight Viz supports evaluation of dynamic MR data acquired from breast studies during contrast administration. TumorSight Viz performs processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats).
TumorSight Viz also includes user-configurable features for visualizing and analyzing findings in breast MRI studies. Patient management decisions should not be made based solely on the results of TumorSight Viz.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251766: TumorSight Viz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251766
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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