510(k) · Cleared
Recalled · Class II · 2017Cedara Webaccess, Model: 2.4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cedara Software Corp. · LLZ System, Image Processing, Radiological
Cleared on Jun 23, 2010 as substantially equivalent to K022881 (Cedara Software Corp., 2002) and 1 other predicate after a 274-day review. Its family tree reaches back 4 generations to 1991. 21 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 23, 2010
- Review
- 274 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904519 (1991). 10 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 3 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 2 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 1 generation backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- This deviceK092915 Cedara Webaccess, Model: 2.4Cedara Software Corp. · 2010
- Descendant · cites it directly · 16 of its ownK111892 Vitreaview Software 6.1Vital Images, Inc. · 2011
- Descendant · 2 generations on · 15 of its ownK122136 VitreaviewVital Images, Inc. · 2012
- Descendant · 3 generations on · 8 of its ownK150738 VitreaViewVital Images, Inc. · 2015
- Descendant · 4 generations on · 7 of its ownK163232 Vitrea ViewVital Images, Inc. · 2017
- Descendant · 5 generations on · 6 of its ownK190764 SurgicalARMedivis, Inc. · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K111892Vitreaview Software 6.1Vital Images, Inc. · 2011 · cites it directly16descendants
- K122136VitreaviewVital Images, Inc. · 2012 · 2 generations on15descendants
- K150738VitreaViewVital Images, Inc. · 2015 · 3 generations on8descendants
- K163232Vitrea ViewVital Images, Inc. · 2017 · 4 generations on7descendants
- K190764SurgicalARMedivis, Inc. · 2019 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −3 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −2 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −1 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| 0 (this device) | K092915 | Cedara Webaccess, Model: 2.4 | Cedara Software Corp. | 2010 | — |
| +1 | K111892 | Vitreaview Software 6.1 | Vital Images, Inc. | 2011 | — |
| +2 | K122136 | Vitreaview | Vital Images, Inc. | 2012 | — |
| +3 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| +4 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| +5 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K022881 | Cedara I-SoftviewSummary page 1…Trade Name 510(k) Submitter/Manufacturer 510(k) Number Cedara I-SoftView Cedara Software Corp. K022881 WebPax Heart Imaging Technologies, LLC K05 1325 Device Description: Cedara WebAccess… | 2002 |
| * | K051325 | Webpax, Model 200Summary page 1…Cedara I-SoftView Cedara Software Corp. K022881 WebPax Heart Imaging Technologies, LLC K05 1325 Device Description: Cedara WebAccess 2.4 provides medical specialists with access to diagnostic quality images, reports, and v… | 2005 |
What descends from it? (21)
See all 212 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2017 | Class II | Z-2601-2017 | Software design (manufacturing process) | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. |
| May 25, 2016 | Class II | Z-0611-2017 | Software design | Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. |
| Jan 30, 2016 | Class II | Z-2531-2016 | Software design | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were… |
| Jan 30, 2016 | Class II | Z-2532-2016 | Software design | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K111892 (Vital Images, Inc., 2011) has gone furthest, with 16 descendants of its own.
- 5 other devices also cite its predicate K022881.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the…
Read the full statement (146 words)
Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.
Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.
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/K092915 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092915: Cedara Webaccess, Model: 2.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092915
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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