510(k) · Cleared
ClearedVeolity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MeVis Medical Solutions AG · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Feb 23, 2021 as substantially equivalent to K043617 (Hologic, Inc., 2007) and 3 other predicates after a 263-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Feb 23, 2021
- Review
- 263 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K913770 (1991). 38 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
- 1 generation backK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- This deviceK201501 VeolityMeVis Medical Solutions AG · 2021
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 5 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 4 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
- 1 generation backK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- This deviceK201501 VeolityMeVis Medical Solutions AG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −5 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −4 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −3 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −2 | K151283 | Lung Analysis Software | Vital Images, Inc. | 2015 | — |
| −1 | K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | 2017 | — |
| 0 (this device) | K201501 | Veolity | MeVis Medical Solutions AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 OEB? 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 OEB device
- #1 K254075 Synapse Lung Nodule AIscore 14.4 · 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 |
|---|---|---|---|
| * | K043617 | Imagechecker CT Cad Software SystemSummary page 5…005-1 3 Predicate Devices 510(k) Number Predicate Device Product Code K043617 ImageChecker CT CAD Software System OEB K023003 ImageChecker-CT Workstation… | 2007 |
| * | K023003 | Imagechecker-CT WorkstationSummary page 5…mber Predicate Device Product Code K043617 ImageChecker CT CAD Software System OEB K023003 ImageChecker-CT Workstation LLZ K040028 Comprehensive Chest Analysis To… | 2002 |
| * | K040028 | CA-1500Summary page 5…43617 ImageChecker CT CAD Software System OEB K023003 ImageChecker-CT Workstation LLZ K040028 Comprehensive Chest Analysis Tools (C-CAT) LLZ 4 Reference Device 510(k) Number Refe… | 2004 |
| * | K162484 | Lung Nodule Assessment and Comparison Option (LNA)Summary page 5…t Analysis Tools (C-CAT) LLZ 4 Reference Device 510(k) Number Reference Device Product Code K162484 Lung Nodule Assessment and Comparison Option LLZ, JAK (LNA) 5 Device Desc… | 2017 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 38 ancestors have a recall of any class.
How does its category compare?
All OEB devicesOEB Lung Computed Tomography System, Computer-Aided Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OEB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OEB
229in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OEB
No recall names OEB since 2007.
Adverse event reports per year · OEB
No MAUDE report names OEB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 229 | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Veolity is intended to: display a composite view of 2D cross-sections, and 3D volumes of chest CT images, allow comparison between new and previous acquisitions as well as abnormal thoracic regions of interest, such as pulmonary nodules, provide Computer-Aided Detection (“CAD”) findings, which assist radiologists in the detection of solid pulmonary nodules between 4-30 mm in size in CT images with or without intravenous contrast. CAD is intended to be…
Read the full statement (212 words)
Veolity is intended to:
display a composite view of 2D cross-sections, and 3D volumes of chest CT images,
allow comparison between new and previous acquisitions as well as abnormal thoracic regions of interest, such as pulmonary nodules,
provide Computer-Aided Detection (“CAD”) findings, which assist radiologists in the detection of solid pulmonary nodules between 4-30 mm in size in CT images with or without intravenous contrast. CAD is intended to be used as an adjunct, alerting the radiologist — after his or her initial reading of the scan — to regions of interest that may have been initially overlooked.
The system can be used with any combination of these features. Enabling/disabling is handled via licensing or configuration options.
Intended Patient Population:
Veolity is an imaging software including computer assisted reading tools for reviewing CT examinations of the chest on an asymptomatic population.
Intended Conditions of Use:
As a software-only product, Veolity does not come into direct contact or indirect contact with patients, and it is neither a sterile device nor an in vitro diagnostic device. Additionally, the environmental and location requirements as defined for the hardware running Veolity apply. The software does not alter these requirements.
Intended User Profile:
Veolity is intended to be used by medical professionals (e.g., radiologists) with adequate training.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201501: Veolity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201501
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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