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 Sep 7, 2012 as substantially equivalent to K111892 (Vital Images, Inc., 2011) after a 51-day review. Its family tree reaches back 6 generations to 1991. 15 later devices descend from it.
- Decided
- Sep 7, 2012
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904519 (1991). 12 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 4 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 3 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 2 generations backK092915 Cedara Webaccess, Model: 2.4Cedara Software Corp. · 2010 · Recalled
- 1 generation backK111892 Vitreaview Software 6.1Vital Images, Inc. · 2011
- This deviceK122136 VitreaviewVital Images, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK150738 VitreaViewVital Images, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK163232 Vitrea ViewVital Images, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK190764 SurgicalARMedivis, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK121916 IntuitionTerarecon,Inc. · 2013 · Recalled
- Descendant · 4 generations on · 2 of its ownK213215 VSI HoloMedicineApoqlar GmbH · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K150738VitreaViewVital Images, Inc. · 2015 · cites it directly8descendants
- K163232Vitrea ViewVital Images, Inc. · 2017 · 2 generations on7descendants
- K190764SurgicalARMedivis, Inc. · 2019 · 3 generations on6descendants
- K121916IntuitionTerarecon,Inc. · 2013 · cites it directly5descendants
- K213215VSI HoloMedicineApoqlar GmbH · 2022 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −5 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −4 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −3 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −2 | K092915 | Cedara Webaccess, Model: 2.4 | Cedara Software Corp. | 2010 | 4 |
| −1 | K111892 | Vitreaview Software 6.1 | Vital Images, Inc. | 2011 | — |
| 0 (this device) | K122136 | Vitreaview | Vital Images, Inc. | 2012 | — |
| +1 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| +2 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| +3 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| +1 | K121916 | Intuition | Terarecon,Inc. | 2013 | 1 |
| +4 | K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K111892 | Vitreaview Software 6.1Summary page 1…cture Archiving and Communications System Classification Name: System, Image Processing, Radiological (21 C.F.R. 892.2050,LLZ) Predicate Device: VitreaView (K111892) Device Description: VitreaView is a cross-browser, cross-platform, zero-footprint universal image viewer solution capable of di… | 2011 |
What descends from it? (15)
See all 152 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 21 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K150738 (Vital Images, Inc., 2015) has gone furthest, with 8 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. 2012, 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, that may be hosted within disparate archives and repositories for review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for primary diagnosis. When accessed from a mobile tablet…
Read the full statement (145 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, that may be hosted within disparate archives and repositories for
review, communication and reporting of DICOM and non-DICOM data. VitreaView is not intended for
primary diagnosis. When accessed from a mobile tablet, VitreaView is for informational purposes only
and not intended for diagnostic use.
Display monitors used for reading medical images for diagnostic purposes must comply with
applicable regulatory approvals and with quality control requirements for their use and maintenance.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for
primary image interpretations. Mammographic images may only be interpreted using an FDA
approved monitor that offers at least 5 MP resolution and meets other technical specifications
reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K122136: Vitreaview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K122136
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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