510(k) · Cleared
ClearedSurgicalAR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medivis, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 13, 2019 as substantially equivalent to K163232 (Vital Images, Inc., 2017) after a 49-day review. Its family tree reaches back 12 generations to 1991. 6 later devices descend from it.
- Decided
- May 13, 2019
- Review
- 49 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913770 (1991). 53 ancestors in all, the oldest K896095 (1990). 6 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- 2 generations backK150738 VitreaViewVital Images, Inc. · 2015
- 1 generation backK163232 Vitrea ViewVital Images, Inc. · 2017
- This deviceK190764 SurgicalARMedivis, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK213215 VSI HoloMedicineApoqlar GmbH · 2022
- Descendant · cites it directly · 1 of its ownK230249 IkshanaImmersivetouch · 2023
- Descendant · 2 generations on · 0 of its ownK253486 SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK251577 Laia XRAugmented Reality Software S.L. · 2026
- Descendant · 2 generations on · 0 of its ownK240094 LumiNE US; LumiAugmedit B.V. · 2024
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 10 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 9 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 8 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 7 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 6 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 5 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 4 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 3 generations backK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- 2 generations backK150738 VitreaViewVital Images, Inc. · 2015
- 1 generation backK163232 Vitrea ViewVital Images, Inc. · 2017
- This deviceK190764 SurgicalARMedivis, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213215VSI HoloMedicineApoqlar GmbH · 2022 · cites it directly2descendants
- K230249IkshanaImmersivetouch · 2023 · cites it directly1descendant
- K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026 · 2 generations on0descendants
- K251577Laia XRAugmented Reality Software S.L. · 2026 · 2 generations on0descendants
- K240094LumiNE US; LumiAugmedit B.V. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −10 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −9 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −8 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −7 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −6 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −5 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −4 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −3 | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | 3 |
| −2 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| −1 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| 0 (this device) | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| +1 | K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022 | — |
| +1 | K230249 | Ikshana | Immersivetouch | 2023 | — |
| +2 | K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026 | — |
| +2 | K251577 | Laia XR | Augmented Reality Software S.L. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K163232 | Vitrea ViewSummary page 4…II Panel: Radiology Product Code: LLZ Predicate Device: VitreaView (K163232) 5.1 Device Description SurgicalAR is a software platform to be used by clinicians for the visualization of medical images in 3… | 2017 |
What descends from it? (6)
3 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 28 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 14 of the 53 ancestors have a recall of any class.
- Of its descendants, K213215 (Apoqlar GmbH, 2022) has gone furthest, with 2 descendants 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. 2019, 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?
SurgicalAR is a software device for display of medical images and other healthcare data. It includes functions for image review image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering). Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical…
Read the full statement (162 words)
SurgicalAR is a software device for display of medical images and other healthcare data. It includes functions for image review image manipulation, basic measurements and 3D visualization (MPR reconstructions and 3D volume rendering).
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Surgical AR software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians and technologists.
When accessing Surgical AR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
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/K190764 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190764: SurgicalAR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190764
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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