510(k) · Cleared
ClearedPhillips Easy Vision Family Workstation Option Endo 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 8, 1998 after an 80-day review. The FDA summary names its predicate without a number. 49 later devices descend from it.
- Decided
- Jan 8, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 1 citing it directly.
- This deviceK973983 Phillips Easy Vision Family Workstation Option Endo 3DPhilips Medical Systems, Inc. · 1998
- Descendant · cites it directly · 48 of its ownK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
- Descendant · 2 generations on · 14 of its ownK061421 Erad PacsErad, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK050228 Agfa Heartlab CardiovascularHeartlab, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 7 of its ownK120995 Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012
- Descendant · 3 generations on · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Agfa Corp. · 2002 · cites it directly48descendants
- K061421Erad PacsErad, Inc. · 2006 · 2 generations on14descendants
- K050228Agfa Heartlab CardiovascularHeartlab, Inc. · 2005 · 2 generations on9descendants
- K120995Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software ProductErad, Inc. · 2012 · 3 generations on7descendants
- K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973983 | Phillips Easy Vision Family Workstation Option Endo 3D | Philips Medical Systems, Inc. | 1998 | — |
| +1 | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | 9 |
| +2 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| +2 | K050228 | Agfa Heartlab Cardiovascular | Heartlab, Inc. | 2005 | 22 |
| +3 | K120995 | Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product | Erad, Inc. | 2012 | — |
| +3 | K053133 | Syngo Dynamics, Version 5.0 | Siemens Medical Solutions USA, Inc. | 2005 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | — | General Electric Medical Systems - Avantage Windows 3D with Navigator Option Named without a submission number |
What descends from it? (49)
See all 491 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology… | 2002 | 48 |
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?
- Of its descendants, K022292 (Agfa Corp., 2002) has gone furthest, with 48 descendants 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.
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?
The Easyvision Endo 3D Option is intended for use when visualization and assessment of anatomy from a perspective different from the original CT or MR data set’s perspective may be either useful or necessary. This perspective can be external or internal; for example looking down on the cortex or looking inside the aorta. “The Endo 3D option also provides visualization of structures to facilitate surgical planning.
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/K973983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973983: Phillips Easy Vision Family Workstation Option Endo 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973983
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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