510(k) · Cleared
ClearedVitrea View
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 Jul 21, 2017 as substantially equivalent to K150738 (Vital Images, Inc., 2015) after a 246-day review. Its family tree reaches back 11 generations to 1991. 7 later devices descend from it.
- Decided
- Jul 21, 2017
- Review
- 246 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913770 (1991). 52 ancestors in all, the oldest K896095 (1990). 7 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- 1 generation backK150738 VitreaViewVital Images, Inc. · 2015
- This deviceK163232 Vitrea ViewVital Images, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK190764 SurgicalARMedivis, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK213215 VSI HoloMedicineApoqlar GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK230249 IkshanaImmersivetouch · 2023
- Descendant · 3 generations on · 0 of its ownK253486 SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK251577 Laia XRAugmented Reality Software S.L. · 2026
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- 1 generation backK150738 VitreaViewVital Images, Inc. · 2015
- This deviceK163232 Vitrea ViewVital Images, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190764SurgicalARMedivis, Inc. · 2019 · cites it directly6descendants
- K213215VSI HoloMedicineApoqlar GmbH · 2022 · 2 generations on2descendants
- K230249IkshanaImmersivetouch · 2023 · 2 generations on1descendant
- K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc. · 2026 · 3 generations on0descendants
- K251577Laia XRAugmented Reality Software S.L. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −2 | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | 3 |
| −1 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| 0 (this device) | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| +1 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| +2 | K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022 | — |
| +2 | K230249 | Ikshana | Immersivetouch | 2023 | — |
| +3 | K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026 | — |
| +3 | K251577 | Laia XR | Augmented Reality Software S.L. | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K150738 | VitreaViewSummary page 4…510(k) clearance for the Vitrea View software which we believe is Submission: substantially equivalent to the FDA cleared VitreaView (K150738). Vital Images, Inc. Submitter: 5850 Opus Parkway, Suite 300 M… | 2015 |
| † | K140909 | Mckesson Radiology | 2014 |
| † | K111804 | Intellispace Pacs 4.X | 2011 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190764 | SurgicalAR | 2019 | 6 |
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 26 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 14 of the 52 ancestors have a recall of any class.
- Of its descendants, K190764 (Medivis, Inc., 2019) has gone furthest, with 6 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. 2017, 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?
Vitrea View software 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 (including mammography and digital breast tomosynthesis), 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. Lossy…
Read the full statement (181 words)
Vitrea View software 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 (including mammography and digital breast tomosynthesis), 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.
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.
Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
When accessing Vitrea View software 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/K163232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163232: Vitrea View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163232
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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