510(k) · Cleared
ClearedLumiNE US; Lumi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augmedit B.V. · QIH Automated Radiological Image Processing Software
Cleared on Sep 10, 2024 as substantially equivalent to K213215 (Apoqlar GmbH, 2022) after a 242-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Sep 10, 2024
- Review
- 242 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K913770 (1991). 55 ancestors in all, the oldest K896095 (1990). No later device cites it as a predicate yet.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK163232 Vitrea ViewVital Images, Inc. · 2017
- 2 generations backK190764 SurgicalARMedivis, Inc. · 2019
- 1 generation backK213215 VSI HoloMedicineApoqlar GmbH · 2022
- This deviceK240094 LumiNE US; LumiAugmedit B.V. · 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 backK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- 4 generations backK150738 VitreaViewVital Images, Inc. · 2015
- 3 generations backK163232 Vitrea ViewVital Images, Inc. · 2017
- 2 generations backK190764 SurgicalARMedivis, Inc. · 2019
- 1 generation backK213215 VSI HoloMedicineApoqlar GmbH · 2022
- This deviceK240094 LumiNE US; LumiAugmedit B.V. · 2024
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 | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | 3 |
| −4 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| −3 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| −2 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| −1 | K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022 | — |
| 0 (this device) | K240094 | LumiNE US; Lumi | Augmedit B.V. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K213215 | VSI HoloMedicineSummary page 6…umiNE US Trade name: LumiNE US, Lumi 2 Predicate Device Information Trade or proprietary or model name: VSI Holomedicine Original Applicant: ApoQlar GmbH 510(k) Number: K213215 Regulation Number: 21 CFR 892.2050 3 Description of the Device LumiNE US is a software device for the visualization of medical i… | 2022 |
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 33 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 14 of the 55 ancestors have a recall of any class.
- 1 other device also cites its predicate K213215.
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. 2024, 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?
The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational…
Read the full statement (267 words)
The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE US software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use.
The LumiNE US software is intended for use by a (neuro)surgeon, (neuro)surgical resident or a medical professional that is qualified by a hospital to prepare medical imaging for surgeons. For the conversion of medical imaging into 3D models, Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) imaging of adult patients are required. The LumiNE US software is intended to be used for visualization in preparation of surgery, and not for diagnostic use. Therefore, segmentation and visualization of tumors or any other pathology can only be used for previously known and pre-diagnosed conditions.
LumiNE US can only be used for contrast-enhanced T1 MR scans (semi-automatic segmentation of known tumor, skin, brain, and ventricles), or for CT scans (threshold-based segmentation).
The LumiNE US MRI T1 tumor segmentation function can only be used in case of a single intracranial contrast enhancing tumor, diagnosed by a neuroradiologist or a neurosurgeon, with a minimal volume of 2.0 cc (0.1 in3) and a minimal diameter in any direction of 15 mm (0.6 inch), and a maximum volume of 100cc (6.1 in3) and a maximal diameter in any direction of 75 mm (3.0 inch).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240094: LumiNE US; Lumi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240094
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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