510(k) · Cleared
ClearedLumys (V1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intradys · LLZ System, Image Processing, Radiological
Cleared on May 2, 2025 as substantially equivalent to K221796 (Abys Medical, 2022) after a 217-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- May 2, 2025
- Review
- 217 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K913770 (1991). 169 ancestors in all, the oldest K890348 (1989). No later device cites it as a predicate yet.
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations between
- 3 generations backK160371 NovaPACSNovarad Corporation · 2016
- 2 generations backK171754 NovaPACSNovarad Corporation · 2017 · Recalled
- 1 generation backK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- This deviceK243069 Lumys (V1)Intradys · 2025
Show all 15 generations
- Root · 15 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 14 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 13 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 12 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 11 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 10 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 9 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 8 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 7 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 6 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 5 generations backK072821 Vitrea 4DCTVital Images, Inc. · 2008 · Recalled
- 4 generations backK132853 NovapacsNovarad Corp. · 2014 · Recalled
- 3 generations backK160371 NovaPACSNovarad Corporation · 2016
- 2 generations backK171754 NovaPACSNovarad Corporation · 2017 · Recalled
- 1 generation backK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- This deviceK243069 Lumys (V1)Intradys · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −14 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −13 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −12 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −11 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −10 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −9 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −8 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −7 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −6 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −5 | K072821 | Vitrea 4DCT | Vital Images, Inc. | 2008 | 1 |
| −4 | K132853 | Novapacs | Novarad Corp. | 2014 | 2 |
| −3 | K160371 | NovaPACS | Novarad Corporation | 2016 | — |
| −2 | K171754 | NovaPACS | Novarad Corporation | 2017 | 1 |
| −1 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| 0 (this device) | K243069 | Lumys (V1) | Intradys | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 19 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 15 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K221796 | Cyware 4H and Cysart 4HSummary page 5…mber: 892.2050 Product Code(s): LLZ Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221796 Cysware 4H and Cysart 4H LLZ Device Description Summary LUMYS is a data visualiz… | 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 34 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 46 of the 169 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out pre-surgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement. LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual…
Read the full statement (190 words)
LUMYS is intended for use as a software interface and image segmentation system, which is used to carry out pre-surgical planning tasks. LUMYS is intended to be used by clinicians with appropriate clinical judgement.
LUMYS is a medical display software intended for 3D image visualization and image interaction. The stereoscopic 3D images are generated from 3D volumetric data acquired from a CT scan source. The device is intended to provide visual information to be used by clinicians with appropriate clinical judgement for analysis of surgical options, and the intraoperative display of the images. The primary surgeon wears a Microsoft Hololens™ Head Mounted Display (HMD) and consults with external users who can perform pre-surgical tasks such as annotating 3D images, uploading files and speaking with the surgeon. The surgeon must cease communication once surgery begins.
LUMYS is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. LUMYS is intended to be used as a reference display consultation software, which assists the clinician with appropriate clinical judgement who is responsible for making all final patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243069: Lumys (V1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243069
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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