510(k) · Cleared
ClearedAze Virtualplace
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 Mar 9, 2006 as substantially equivalent to K052995 (GE Healthcare, 2005) and 4 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Mar 9, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K954678 (1996). 31 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 1 generation backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- This deviceK060453 Aze VirtualplaceAze, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK133521 Aze Phoenix SoftwareAze, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133521Aze Phoenix SoftwareAze, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −1 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| 0 (this device) | K060453 | Aze Virtualplace | Aze, Ltd. | 2006 | — |
| +1 | K133521 | Aze Phoenix Software | Aze, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (5)
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 |
|---|---|---|---|
| * | K052995 | Advantage Workstation 4.3.Summary page 1…ices The AZE VirtualPlace is substantially equivalent in intended use, function, and features to the currently marketed devices: GE Advantage Workstation 4.3, K052995; Philips Medical Systems ViewForum 2003, K032096; MeVis LiverAnalyser / LiverViewer Software from MeVis Technol… | 2005 |
| * | K032096 | Philips Viewforum 2003Summary page 1…intended use, function, and features to the currently marketed devices: GE Advantage Workstation 4.3, K052995; Philips Medical Systems ViewForum 2003, K032096; MeVis LiverAnalyser / LiverViewer Software from MeVis Technology GmbH & Co. KG, K051528; QBra… | 2003 |
| * | K051528 | Mevis Liveranalyser/Liverviewer SoftwareSummary page 1…2995; Philips Medical Systems ViewForum 2003, K032096; MeVis LiverAnalyser / LiverViewer Software from MeVis Technology GmbH & Co. KG, K051528; QBrain software from Medis Medical Imaging Systems, B.V., K050703; BrainViewRx Viewer Version 1.0 from Kyron C… | 2005 |
| * | K050703 | QbrainSummary page 1…is LiverAnalyser / LiverViewer Software from MeVis Technology GmbH & Co. KG, K051528; QBrain software from Medis Medical Imaging Systems, B.V., K050703; BrainViewRx Viewer Version 1.0 from Kyron Clinical Imaging, Inc., K052467. Device Description The AZE VirtualPlace u… | 2005 |
| * | K052467 | Brain Viewrx Viewer, Version 1.0Summary page 1…KG, K051528; QBrain software from Medis Medical Imaging Systems, B.V., K050703; BrainViewRx Viewer Version 1.0 from Kyron Clinical Imaging, Inc., K052467. Device Description The AZE VirtualPlace utilizes DICOM images as it facilitates reviewing, printing, storing, communications… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133521 | Aze Phoenix Software | 2014 | 0 |
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 10 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 31 ancestors have a recall of any class.
- Of its descendants, K133521 (Aze, Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K052995.
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?
AZE VirtualPlace is an image processing workstation that accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, communication, printing and quantification. When interpreted by a trained physician, filmed or displayed images on the VirtualPlace monitor may be used as a basis for diagnosis, except in the case…
Read the full statement (115 words)
AZE VirtualPlace is an image processing workstation that accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, communication, printing and quantification. When interpreted by a trained physician, filmed or displayed images on the VirtualPlace monitor may be used as a basis for diagnosis, except in the case of mammography images. 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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060453: Aze Virtualplace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060453
Report an extraction error
Are you the manufacturer?
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