510(k) · Cleared
ClearedAze Phoenix Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aze, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 11, 2014 as substantially equivalent to K060453 (Aze, Ltd., 2006) and 2 other predicates after a 147-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Apr 11, 2014
- Review
- 147 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K913770 (1991). 146 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK133521 Aze Phoenix SoftwareAze, Ltd. · 2014
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK133521 Aze Phoenix SoftwareAze, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| 0 (this device) | K133521 | Aze Phoenix Software | Aze, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 6 | 0 |
| 2004 | 12 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 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? (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 |
|---|---|---|---|
| * | K060453 | Aze VirtualplaceSummary page 1…ion: Picture, archiving, and communication system Class: 11 Product Code: LLZ Classification Panel: 892.2050 Predicate Device(s): K060453, VirtualPlace, AZE, Ltd. K093621, syngo.PET & CT Oncology, Siemens AG Healthcare SY… | 2006 |
| * | K093621 | Syngo.Pet&CT OncologySummary page 1…Class: 11 Product Code: LLZ Classification Panel: 892.2050 Predicate Device(s): K060453, VirtualPlace, AZE, Ltd. K093621, syngo.PET & CT Oncology, Siemens AG Healthcare SY K123375, syngovia, Siemens AG Healthcare SY' Device… | 2010 |
| * | K123375 | Syngo.ViaSummary page 1…0 Predicate Device(s): K060453, VirtualPlace, AZE, Ltd. K093621, syngo.PET & CT Oncology, Siemens AG Healthcare SY K123375, syngovia, Siemens AG Healthcare SY' Device Description: AZE Phoenix is a distributed client-server radiological review sta… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 38 of the 146 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list.…
Read the full statement (226 words)
AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual inspection of individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images, individual images may be loaded into AZE VirtualPlaceTM workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlaceTM workstation.
AZE Phoenix is not indicated for mammography use. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Manimographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
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/K133521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133521: Aze Phoenix Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133521
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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