510(k) · Cleared
ClearedInnova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · LLZ System, Image Processing, Radiological
Cleared on Dec 2, 2009 as substantially equivalent to K852353 (Thomson-Cgr Medical Corp., 1985) and 2 other predicates after a 97-day review. Its family tree reaches back 4 generations to 1991. 65 later devices descend from it.
- Decided
- Dec 2, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K913770 (1991). 12 ancestors in all, the oldest K852353 (1985). 65 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 2 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 1 generation backK052995 Advantage Workstation 4.3.GE Healthcare · 2005 · Recalled
- This deviceK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- Descendant · cites it directly · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 2 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · 3 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
- Descendant · 4 generations on · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
- Descendant · 5 generations on · 27 of its ownK181485 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70…Philips Ultrasound, Inc. · 2018 · Recalled
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · cites it directly41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 2 generations on39descendants
- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 3 generations on32descendants
- K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · 4 generations on28descendants
- K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · 5 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −2 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −1 | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | 4 |
| 0 (this device) | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| +1 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +2 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +3 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
| +4 | K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound… | Philips Health Care | 2017 | 31 |
| +5 | K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic… | Philips Ultrasound, Inc. | 2018 | 24 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K852353 | DG 200/300 Digital Angiographic SystemSummary page 1…mmunications system Product Code: LLZ 21CFR 892.2050 Predicate Devices: Manufactured by GE Medical Systems: * K852353 DG 200/300 Digital Angiographic System * K0920041Innova 4100'Q, 3100!O, 2100'Q with StentViz… | 1985 |
| Kept off the family tree | K090041 | Innova 4100, 3100, 2100 with StentViz Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K052995 | Advantage Workstation 4.3.Summary page 1…53 DG 200/300 Digital Angiographic System * K0920041Innova 4100'Q, 3100!O, 2100'Q with StentViz * K052995 Advantage Workstation * K<041521 Volume Viewer plus Manufactur… | 2005 |
| * | K041521 | Volume Viewer PlusSummary page 1…* K0920041Innova 4100'Q, 3100!O, 2100'Q with StentViz * K052995 Advantage Workstation * K<041521 Volume Viewer plus Manufactured by Philips: 1062650 EP-Navi… | 2004 |
| * | — | EP-Navigator Named without a submission number |
What descends from it? (65)
See all 657 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101311 | EP Navigator R3 | 2010 | 41 |
| K121772 | Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 | 2013 | 15 |
| K210830 | VUZE System | 2022 | 1 |
| K152352 | Stereo 3D option for Vision Applications | 2016 | 1 |
| K131263 | Xperguide | 2013 | 1 |
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | 2022 | 0 |
| K130069 | Innova Epvision 2.0, Innova Epvision 2.0 | 2013 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K101311 (Philips Medical Systems North America Co., 2010) has gone furthest, with 41 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. 2009, 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?
Innova Vision Applications software is intended to enable users to load 3D datasets and overlay and register in real time these 3D datasets with radioscopic or radiographic images of the same anatomy in order to support catheter/device guidance during interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092639 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092639
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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