510(k) · Cleared
ClearedFlightPlan for Embolization
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 Mar 21, 2023 as substantially equivalent to K193261 (GE Medical Systems SCS, 2020) after a 120-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Mar 21, 2023
- Review
- 120 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K871859 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 4 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 3 generations backK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
- 2 generations backK121200 Flightplan for LiverGE Healthcare · 2012
- 1 generation backK193261 FlightPlan for EmbolizationGE Medical Systems SCS · 2020
- This deviceK223490 FlightPlan for EmbolizationGE Medical Systems SCS · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −4 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −3 | K041521 | Volume Viewer Plus | General Electric Medical Systems | 2004 | 2 |
| −2 | K121200 | Flightplan for Liver | GE Healthcare | 2012 | — |
| −1 | K193261 | FlightPlan for Embolization | GE Medical Systems SCS | 2020 | — |
| 0 (this device) | K223490 | FlightPlan for Embolization | GE Medical Systems SCS | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K193261 | FlightPlan for EmbolizationSummary page 4…: Class II Predicate Device: Device Name: FlightPlan for Embolization Manufacturer: GE Medical Systems SCS 510(k) number: K193261 Regulation Number: 21CFR 892.2050, Medical image management and processing system Product Code: LLZ Regulat… | 2020 |
| † | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | 2018 |
| † | K110834 | AW Volumeshare 5 with Angioviz Option | 2011 |
| † | K081985 | AW Server | 2008 |
| † | K041521 | Volume Viewer Plus | 2004 |
| † | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 5 companies; a new generation was cleared every 7.2 years on median.
- 3 of the 8 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery. The output includes segmented vasculature, and selective display of proximal vessel and distal vessels…
Read the full statement (111 words)
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. FlightPlan for Embolization is not intended to be used during therapy delivery.
The output includes segmented vasculature, and selective display of proximal vessel and distal vessels from a reference point determined by the user. User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223490 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223490: FlightPlan for Embolization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223490
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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