510(k) · Cleared
ClearedCedara I-Response Cedara Pet/CT
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 Feb 3, 2006 as substantially equivalent to K040468 (Cedara Software Corp., 2004) and 1 other predicate after a 67-day review. Its family tree reaches back 6 generations to 1991. 1 of the 237 devices in its family, counting itself, has a Class I recall. 221 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K913770 (1991). 15 ancestors in all, the oldest K904519 (1991). 221 later devices descend from it, 3 citing it directly. 1 of the 237 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 1 generation backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- This deviceK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · cites it directly · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 3 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 4 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 221 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 221 · See all- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · cites it directly201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 3 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 3 generations on70descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 4 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −4 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −3 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −1 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| 0 (this device) | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +1 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 15 | 0 |
| 2022 | 21 | 0 |
| 2023 | 18 | 0 |
| 2024 | 21 | 0 |
| 2025 | 23 | 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 21.5 · 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 |
|---|---|---|---|
| * | K040468 | Cedara I-Softview and Cedara I-ReadmammoSummary page 1…Name: Medical image processing software Classification Name: Picture archiving and communications system Predicate Devices: Cedara I-SoftView, 5 10(k) No. K040468 Siemens syngo TrueD, 5 10(k) No. K041484 Device Description: The Cedfra [-Response and Cedara PET/CT s… | 2004 |
| * | K041484 | UndecidedSummary page 1…Name: Picture archiving and communications system Predicate Devices: Cedara I-SoftView, 5 10(k) No. K040468 Siemens syngo TrueD, 5 10(k) No. K041484 Device Description: The Cedfra [-Response and Cedara PET/CT software products are line extensions to C… | 2004 |
What descends from it? (221)
See all 2213 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)
No FDA recall names this device.
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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K071950 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 201 descendants of its own.
- 3 other devices also cite its predicate K040468.
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. Diagnostic Review Workstations - Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the…
Read the full statement (157 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.
Diagnostic Review Workstations - Assists medical professionals including but not limited to radiologists, surgeons, oncologists, neurologists, and cardiologists in conducting primary diagnostic review and planning through the flexible and itcractivc manip,1lptio1n of multi-modality softeopy images.
Two and three-dimensional image corcgistration (fusion) and segmentation of mulliple imaging modality data including but not limited to functional MRI, PET, SPFCT, ;d CT for user-selected regions of interest taken at different time points or generated using different scanning protocols.
Detailed measurement and reporting features assist clinicians in assessing and documenting changes in regions of interest such as pathologies (e.g., tumors, abscesses, AVMs), or other anatomical structures. The software can help track changes in morphology, functional activity, or other responses that may occur as a result of treatment therapy or disease progression
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053301: Cedara I-Response Cedara Pet/CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053301
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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