510(k) · Cleared
ClearedVitreaView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 6, 2015 as substantially equivalent to K122136 (Vital Images, Inc., 2012) and 1 other predicate after a 17-day review. Its family tree reaches back 10 generations to 1991. 8 later devices descend from it.
- Decided
- Apr 6, 2015
- Review
- 17 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 51 ancestors in all, the oldest K896095 (1990). 8 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- This deviceK150738 VitreaViewVital Images, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK163232 Vitrea ViewVital Images, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK190764 SurgicalARMedivis, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK213215 VSI HoloMedicineApoqlar GmbH · 2022
- Descendant · 3 generations on · 1 of its ownK230249 IkshanaImmersivetouch · 2023
- Descendant · 4 generations on · 0 of its ownK253486 SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- This deviceK150738 VitreaViewVital Images, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K163232Vitrea ViewVital Images, Inc. · 2017 · cites it directly7descendants
- K190764SurgicalARMedivis, Inc. · 2019 · 2 generations on6descendants
- K213215VSI HoloMedicineApoqlar GmbH · 2022 · 3 generations on2descendants
- K230249IkshanaImmersivetouch · 2023 · 3 generations on1descendant
- K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −1 | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | 3 |
| 0 (this device) | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| +1 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| +2 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| +3 | K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022 | — |
| +3 | K230249 | Ikshana | Immersivetouch | 2023 | — |
| +4 | K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K122136 | VitreaviewSummary page 5…edicate Devices: Predicate Device(s) Manufacturer FDA 510(k) number VitreaView Vital Images, Inc. K122136 ViTALConnect Vital Images, Inc. K071362 Device Description: VitreaView is a cross-browser,… | 2012 |
| * | K071362 | Vital Connect 4.1Summary page 5…FDA 510(k) number VitreaView Vital Images, Inc. K122136 ViTALConnect Vital Images, Inc. K071362 Device Description: VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capab… | 2007 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163232 | Vitrea View | 2017 | 7 |
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 24 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 14 of the 51 ancestors have a recall of any class.
- Of its descendants, K163232 (Vital Images, Inc., 2017) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K122136.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data. Display monitors used for reading medical images for diagnostic purposes…
Read the full statement (113 words)
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
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.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150738: VitreaView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150738
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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