510(k) · Cleared
Recalled · Class II · 2013Cedara I-Softview and Cedara I-Readmammo
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 Apr 23, 2004 as substantially equivalent to K022881 (Cedara Software Corp., 2002) after a 59-day review. Its family tree reaches back 4 generations to 1991. 1 of the 262 devices in its family, counting itself, has a Class I recall. 255 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 2004
- Review
- 59 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904519 (1991). 6 ancestors in all. 255 later devices descend from it, 4 citing it directly. 1 of the 262 devices in this family, counting this one, has a Class I recall.
- 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 deviceK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004
- Descendant · cites it directly · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · 2 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 4 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 4 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
Showing 5 of 255 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 255 · See all- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · cites it directly221descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 4 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 4 generations on70descendants
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) | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | — |
| +1 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +2 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +4 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +4 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 12 | 0 |
| 2017 | 11 | 0 |
| 2018 | 21 | 0 |
| 2019 | 13 | 0 |
| 2020 | 22 | 0 |
| 2021 | 19 | 0 |
| 2022 | 22 | 0 |
| 2023 | 19 | 0 |
| 2024 | 23 | 0 |
| 2025 | 24 | 1 |
| 2026 | 25 | 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.
1 device in this family has a Class I recall. 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 21.6 · 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 |
|---|---|---|---|
| * | K022881 | Cedara I-SoftviewSummary page 1…Cedara I-SoftView; Cedara I-ReadMammo PACS medical imaging software Picture archiving and communications system. Cedara Software Corp., Cedara I SoftView, 510(k) No. K022881. Cedara I-ReadMammo is medical image review workstation software that is comprised of features that are previously cleared in Ce… | 2002 |
What descends from it? (255)
See all 2554 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2013 | Class II | Z-0748-2014 | Software design | There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K053301 (Cedara Software Corp., 2006) has gone furthest, with 221 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.
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?
Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations ~ Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for…
Read the full statement (164 words)
Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image management display needs in the medical environment from multiple locations within and outside the hospital.
Productivity-Enhancing Second Console Workstations ~ Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians.
Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modality softcopy images including the use of prosthetic template overlays, and including mammography.
Physician’s Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.)
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040468 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040468: Cedara I-Softview and Cedara I-Readmammo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040468
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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