510(k) · Cleared
ClearedImpax Volume Viewing
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 Jun 24, 2011 as substantially equivalent to K080013 (Agfa Healthcare Corporation, 2008) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 2005. 4 later devices descend from it.
- Decided
- Jun 24, 2011
- Review
- 11 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K043441 (2005). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK043441 Mirage, Release 5.5Segami Corporation · 2005
- 1 generation backK080013 Registration and FusionAgfa Healthcare Corporation · 2008
- This deviceK111638 Impax Volume ViewingAgfa Healthcare N.V. · 2011
- Descendant · cites it directly · 3 of its ownK133135 Impax Volume Viewing 3.0Agfa Healthcare N.V. · 2014
- Descendant · 2 generations on · 1 of its ownK142316 IMPAX AgilityAgfa Healthcare N.V. · 2015
- Descendant · 2 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 2 generations on · 0 of its ownK161061 IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016
Most influential descendants
Showing 4 of 4 · See all- K133135Impax Volume Viewing 3.0Agfa Healthcare N.V. · 2014 · cites it directly3descendants
- K142316IMPAX AgilityAgfa Healthcare N.V. · 2015 · 2 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 2 generations on0descendants
- K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K043441 | Mirage, Release 5.5 | Segami Corporation | 2005 | — |
| −1 | K080013 | Registration and Fusion | Agfa Healthcare Corporation | 2008 | — |
| 0 (this device) | K111638 | Impax Volume Viewing | Agfa Healthcare N.V. | 2011 | — |
| +1 | K133135 | Impax Volume Viewing 3.0 | Agfa Healthcare N.V. | 2014 | — |
| +2 | K142316 | IMPAX Agility | Agfa Healthcare N.V. | 2015 | — |
| +2 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +2 | K161061 | IMPAX Volume Viewing 4.0 | Agfa Healthcare N.V. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K080013 | Registration and FusionSummary page 1…ing software, which is an accessory to its Impax picture archiving and communications systems. [t is substantially equivalent to Agfa’s Registration and Fusion software (K080013) in the majority of its functionality and to the Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion (K070831) with respect… | 2008 |
| * | K070831 | Voxar 3D Enterprise with Colonmetrix and Pet/CT PerfusionSummary page 1…quivalent to Agfa’s Registration and Fusion software (K080013) in the majority of its functionality and to the Voxar 3D Enterprise with ColonMetrix and PET/CT Perfusion (K070831) with respect to its vessel viewing functionality. B. DEVICE DESCRIPTION The new device is similar to the predicate devices. Al… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133135 | Impax Volume Viewing 3.0 | 2014 | 3 |
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 6 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133135 (Agfa Healthcare N.V., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K080013.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 velumetric 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…
Read the full statement (118 words)
Impax Volume Viewing 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 velumetric 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).
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/K111638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111638: Impax Volume Viewing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111638
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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