510(k) · Cleared
ClearedVitreaview Software 6.1
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 28, 2011 as substantially equivalent to K092915 (Cedara Software Corp., 2010) after a 23-day review. Its family tree reaches back 5 generations to 1991. 16 later devices descend from it.
- Decided
- Jul 28, 2011
- Review
- 23 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904519 (1991). 11 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 4 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 3 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 2 generations backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- 1 generation backK092915 Cedara Webaccess, Model: 2.4Cedara Software Corp. · 2010 · Recalled
- This deviceK111892 Vitreaview Software 6.1Vital Images, Inc. · 2011
- Descendant · cites it directly · 15 of its ownK122136 VitreaviewVital Images, Inc. · 2012
- Descendant · 2 generations on · 8 of its ownK150738 VitreaViewVital Images, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK163232 Vitrea ViewVital Images, Inc. · 2017
- Descendant · 4 generations on · 6 of its ownK190764 SurgicalARMedivis, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK121916 IntuitionTerarecon,Inc. · 2013 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K122136VitreaviewVital Images, Inc. · 2012 · cites it directly15descendants
- K150738VitreaViewVital Images, Inc. · 2015 · 2 generations on8descendants
- K163232Vitrea ViewVital Images, Inc. · 2017 · 3 generations on7descendants
- K190764SurgicalARMedivis, Inc. · 2019 · 4 generations on6descendants
- K121916IntuitionTerarecon,Inc. · 2013 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −4 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −3 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −2 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| −1 | K092915 | Cedara Webaccess, Model: 2.4 | Cedara Software Corp. | 2010 | 4 |
| 0 (this device) | K111892 | Vitreaview Software 6.1 | Vital Images, Inc. | 2011 | — |
| +1 | K122136 | Vitreaview | Vital Images, Inc. | 2012 | — |
| +2 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| +3 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| +4 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| +2 | K121916 | Intuition | Terarecon,Inc. | 2013 | 1 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K092915 | Cedara Webaccess, Model: 2.4Summary page 1…redicate Device Manufacturer FDA 510(k) Cedara WebAccessTM Cedara Software Corp. K09291 5 - Mississauga, Ontario, Canada Device Description VitreaView is a cross-browser,… | 2010 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122136 | Vitreaview | 2012 | 15 |
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 20 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K122136 (Vital Images, Inc., 2012) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K092915.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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. Vitrea View is not intended for primary diagnosis. Display monitors used for reading…
Read the full statement (128 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. Vitrea View is not intended for primary diagnosis.
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/K111892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111892: Vitreaview Software 6.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111892
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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