510(k) · Cleared
ClearedImpax Volume Viewing 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · LLZ System, Image Processing, Radiological
Cleared on Mar 7, 2014 as substantially equivalent to K111638 (Agfa Healthcare N.V., 2011) and 4 other predicates after a 154-day review. Its family tree reaches back 6 generations to 1991. 3 later devices descend from it.
- Decided
- Mar 7, 2014
- Review
- 154 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K913770 (1991). 20 ancestors in all, the oldest K913475 (1991). 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 1 generation backK053458 WEB1000Agfa Corp. · 2005 · Recalled
- This deviceK133135 Impax Volume Viewing 3.0Agfa Healthcare N.V. · 2014
- Descendant · cites it directly · 1 of its ownK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · cites it directly · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · cites it directly · 0 of its ownK161061 IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016
Most influential descendants
Showing 3 of 3 · See allView 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 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −1 | K053458 | WEB1000 | Agfa Corp. | 2005 | 2 |
| 0 (this device) | K133135 | Impax Volume Viewing 3.0 | Agfa Healthcare N.V. | 2014 | — |
| +1 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +1 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +1 | K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K111638 | Impax Volume ViewingSummary page 2…000 NEW DEVICE PREDICATES PREDICATE K0222921K1116381K053458 K070831 ___________________ K08001 3 3D Volume rendering… | 2011 |
| * | K080013 | Registration and FusionSummary page 1…ng, which is a picture archiving and communications system. It is substantially equivalent to Agfa's IMPAX Volume Viewing 2.0 (KI 11638), Agfa's Registration and Fusion (K080013), Agfa's Web 1000 (K053458) and Voxar's 3D Enterprise with ColonMetrix and PET/CT Perfusion (K07083 1). B. DEVICE DESCRIPTI… | 2008 |
| * | K053458 | WEB1000Summary page 1…iving and communications system. It is substantially equivalent to Agfa's IMPAX Volume Viewing 2.0 (KI 11638), Agfa's Registration and Fusion (K080013), Agfa's Web 1000 (K053458) and Voxar's 3D Enterprise with ColonMetrix and PET/CT Perfusion (K07083 1). B. DEVICE DESCRIPTION The new device is simila… | 2005 |
| * | K070831 | Voxar 3D Enterprise with Colonmetrix and Pet/CT PerfusionSummary page 1…IMPAX Volume Viewing 2.0 (KI 11638), Agfa's Registration and Fusion (K080013), Agfa's Web 1000 (K053458) and Voxar's 3D Enterprise with ColonMetrix and PET/CT Perfusion (K07083 1). B. DEVICE DESCRIPTION The new device is similar to the predicate devices. All are PACS system accessories that allow the… | 2007 |
| * | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Summary page 1…TIAL EQUIVALENCE SUMMARY Agfa's IMPAX Volume Viewing has an Indications for Use statement largely similar to the statements for the predicate devices (KI111638, K053458, K022292, K080013 and K07083 1). Intended uses are the same. As software accessories to PACS systems, the predicate and new devices have t… | 2002 |
| † | K043441 | Mirage, Release 5.5 | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4.3 years on median.
- 6 of the 20 ancestors have a recall of any class.
- Of its descendants, K142316 (Agfa Healthcare N.V., 2015) has gone furthest, with 1 descendant of its own.
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?
IMPAX Volume Viewing software is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital medical image processing tool, with optional functionality to facilitate visualization and measurement of vessel features. Other…
Read the full statement (158 words)
IMPAX Volume Viewing software is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital medical image processing tool, with optional functionality to facilitate visualization and measurement of vessel features.
Other optional functionality is intended for the registration of anatomical (CT) on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).
Web-browser access is available for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133135: Impax Volume Viewing 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133135
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