510(k) · Cleared
Recalled · Class II · 2017Cedara I-Softview
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 Oct 22, 2002 as substantially equivalent to K002936 (Sectra-Imtec AB, 2000) and 2 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1991. 1 of the 419 devices in its family, counting itself, has a Class I recall. 413 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 22, 2002
- Review
- 53 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904519 (1991). 5 ancestors in all. 413 later devices descend from it, 6 citing it directly. 1 of the 419 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 2 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 1 generation backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- This deviceK022881 Cedara I-SoftviewCedara Software Corp. · 2002
- Descendant · cites it directly · 255 of its ownK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- Descendant · 2 generations on · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · 3 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 133 of its ownK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
Showing 5 of 413 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 413 · See all- K040468Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · cites it directly255descendants
- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · 2 generations on221descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
- K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007 · cites it directly133descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −2 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −1 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| 0 (this device) | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | — |
| +1 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| +2 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 19 | 0 |
| 2017 | 20 | 0 |
| 2018 | 28 | 0 |
| 2019 | 19 | 0 |
| 2020 | 33 | 0 |
| 2021 | 31 | 0 |
| 2022 | 32 | 0 |
| 2023 | 32 | 0 |
| 2024 | 34 | 0 |
| 2025 | 49 | 1 |
| 2026 | 45 | 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 21.5 · 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? (3)
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 |
|---|---|---|---|
| * | K002936 | Modification to IDS5 Image Display SystemSummary page 1…ical Image processing software. Classification Name: Picture archiving and communications system. Predicate Devices: Sectra IDS5 image Display System 5 1O(k) No. K002936; Agfa ADC Compact Plus 510(k) No. KO13 138; 1SG Medical Imaging Family of Works… | 2000 |
| * | K013138 | Adc Compact Plus | 2001 |
| * | K941933 | Isg Medical Imaging Family of Workstations (Mifw)Summary page 1…5 1O(k) No. K002936; Agfa ADC Compact Plus 510(k) No. KO13 138; 1SG Medical Imaging Family of Workstations, 510(k) No. K941933. Device Description: The Cedara Orthopedic tool set is a new option available in the Cedara I-SoftView produ… | 1994 |
What descends from it? (413)
See all 4136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040468 | Cedara I-Softview and Cedara I-Readmammo | 2004 | 255 |
| K071972 | Orthopedic Software for Impax Workstations | 2007 | 133 |
| K092915 | Cedara Webaccess, Model: 2.4 | 2010 | 21 |
| K163048 | Smart Stitching Software System, Image Processing, Radiological | 2017 | 0 |
| K130567 | DR Long Length Imaging Software | 2013 | 0 |
| K033825 | Orthopacs | 2004 | 0 |
Has anything in its family been recalled? (1 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. |
| Oct 8, 2015 | Class II | Z-0878-2017 | Software design | Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment. |
| Aug 23, 2007 | Not classified | Z-1243-2007 | Software design | Defects in the Auto Launch functionality make it possible for a mismatch of patient data. |
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 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K040468 (Cedara Software Corp., 2004) has gone furthest, with 255 descendants of its own.
- 3 other devices also cite its predicate K002936.
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 (125 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. This includes the use of prosthetic template overlays
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.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022881: Cedara I-Softview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022881
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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