510(k) · Cleared
ClearedPhilips Easyvision
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 30, 1998 as substantially equivalent to K921219 (Philips Medical Systems, Inc., 1994) and 1 other predicate after a 247-day review. Its family tree reaches back 2 generations to 1991. 74 later devices descend from it.
- Decided
- Jan 30, 1998
- Review
- 247 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913475 (1991). 4 ancestors in all. 74 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 1 generation backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- This deviceK971965 Philips EasyvisionPhilips 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 · cites it directly · 19 of its ownK031350 3TP Software Option3tp, LLC · 2003 · Recalled
- Descendant · cites it directly · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
- Descendant · 2 generations on · 14 of its ownK061421 Erad PacsErad, Inc. · 2006
- Descendant · cites it directly · 10 of its ownK050862 3TP Workspace3tp, LLC · 2005 · Recalled
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Agfa Corp. · 2002 · cites it directly48descendants
- K0313503TP Software Option3tp, LLC · 2003 · cites it directly19descendants
- K041286Dynacad V1.0Mri Devices Corp. · 2004 · cites it directly17descendants
- K061421Erad PacsErad, Inc. · 2006 · 2 generations on14descendants
- K0508623TP Workspace3tp, LLC · 2005 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −1 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| 0 (this device) | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| +1 | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | 9 |
| +1 | K031350 | 3TP Software Option | 3tp, LLC | 2003 | 1 |
| +1 | K041286 | Dynacad V1.0 | Mri Devices Corp. | 2004 | — |
| +2 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| +1 | K050862 | 3TP Workspace | 3tp, LLC | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K921219 | Philips Dci-SXSummary page 1…station Option Quantitative Analysis Package Classification Name: Image Processing System (90 LLZ) Common/Usual Name: Workstation Predicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows with FuncTool Option (K960265) Intended Use: The CT/MR Quantitative Analysis Package is intended for use… | 1994 |
| * | K960265 | Advantage Windows with Functool OptionSummary page 1…cation Name: Image Processing System (90 LLZ) Common/Usual Name: Workstation Predicate Devices: Philips Gyroview HR (K921219) GE Advantage Windows with FuncTool Option (K960265) Intended Use: The CT/MR Quantitative Analysis Package is intended for use where visualization and analysis of CT and MR dynami… | 1996 |
What descends from it? (74)
See all 746 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 7 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K022292 (Agfa Corp., 2002) has gone furthest, with 48 descendants of its own.
- 1 other device also cites its predicate K921219.
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 CT/MR Quantitative Analysis Package is indicated for use where visualization and analysis of CT and MR dynamic studies, showing changes in contrast over time are useful or necessary.
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/K971965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971965: Philips Easyvision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971965
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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