510(k) · Cleared
Recalled · 2011Philips Viewforum 2003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · LLZ System, Image Processing, Radiological
Cleared on Jul 18, 2003 as substantially equivalent to K920950 (Philips Medical Systems, Inc., 1992) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 1992. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 18, 2003
- Review
- 10 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K920950 (1992). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK920950 Philips EasyvisionPhilips Medical Systems, Inc. · 1992 · Recalled
- 1 generation backK023137 Philips Easyvision Workstation Release 6Philips Medical Systems North America Co. · 2002
- This deviceK032096 Philips Viewforum 2003Philips Medical Systems · 2003
- Descendant · cites it directly · 2 of its ownK081262 DC NeuroInvivo Corporation · 2008
- Descendant · 2 generations on · 1 of its ownK113701 Visia NeuroMeVis Medical Solutions AG · 2012
- Descendant · cites it directly · 1 of its ownK060453 Aze VirtualplaceAze, Ltd. · 2006
- Descendant · 3 generations on · 0 of its ownK141514 Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK133521 Aze Phoenix SoftwareAze, Ltd. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K081262DC NeuroInvivo Corporation · 2008 · cites it directly2descendants
- K113701Visia NeuroMeVis Medical Solutions AG · 2012 · 2 generations on1descendant
- K060453Aze VirtualplaceAze, Ltd. · 2006 · cites it directly1descendant
- K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · 3 generations on0descendants
- K133521Aze Phoenix SoftwareAze, Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920950 | Philips Easyvision | Philips Medical Systems, Inc. | 1992 | 1 |
| −1 | K023137 | Philips Easyvision Workstation Release 6 | Philips Medical Systems North America Co. | 2002 | — |
| 0 (this device) | K032096 | Philips Viewforum 2003 | Philips Medical Systems | 2003 | — |
| +1 | K081262 | DC Neuro | Invivo Corporation | 2008 | — |
| +2 | K113701 | Visia Neuro | MeVis Medical Solutions AG | 2012 | — |
| +1 | K060453 | Aze Virtualplace | Aze, Ltd. | 2006 | — |
| +3 | K141514 | Synapse 3D Tensor Analysis | Fujifilm Meidcal Systems U.S.A.,Inc. | 2014 | — |
| +2 | K133521 | Aze Phoenix Software | Aze, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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 |
|---|---|---|---|
| * | K920950 | Philips EasyvisionSummary page 2…are taken. Substantial equivalence: The Philips ViewForum 2003 is substantially equivalent to the Easyvision Workstation systems (K920950) and Easyvision Workstation Release 6 (KO23137.) Philips Medical Systems Re: KO32096 North… | 1992 |
| * | K023137 | Philips Easyvision Workstation Release 6 | 2002 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2011 | Not classified | Z-1882-2011 | Software design | A software anomaly that occurs when clinicians use Volume Vision to view images in 3D and uses the measurement tool to measure regions of interest. This could lead to an incorrect interpretation of the measurements which could cause an… |
| Apr 29, 2005 | Not classified | Z-0896-05 | Other | Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K081262 (Invivo Corporation, 2008) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K920950.
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?
ViewForum 2003 is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of 'off-the-shelf" standard computer components. ViewForum 2003 software receives image data from medical scanning devices such as CT and MRI, or from image archives. It performs viewing, image manipulation, communication, printing and quantification of images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032096: Philips Viewforum 2003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032096
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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