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 Jan 24, 2020 as substantially equivalent to K121200 (GE Healthcare, 2012) after a 59-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Jan 24, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871859 (1987). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 3 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 2 generations backK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
- 1 generation backK121200 Flightplan for LiverGE Healthcare · 2012
- This deviceK193261 FlightPlan for EmbolizationGE Medical Systems SCS · 2020
- Descendant · cites it directly · 0 of its ownK223490 FlightPlan for EmbolizationGE Medical Systems SCS · 2023
Most influential descendants
Showing 1 of 1 · See all- K223490FlightPlan for EmbolizationGE Medical Systems SCS · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −3 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −2 | K041521 | Volume Viewer Plus | General Electric Medical Systems | 2004 | 2 |
| −1 | K121200 | Flightplan for Liver | GE Healthcare | 2012 | — |
| 0 (this device) | K193261 | FlightPlan for Embolization | GE Medical Systems SCS | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K121200 | Flightplan for LiverSummary page 4…al Name: Picture Archiving and Communications System Classification Names: 21CFR 892.2050, Class II Product Code: LLZ Predicate Device(s): K121200, FlightPlan for Liver Device Description: FlightPlan for Embolization is a post processing software… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223490 | FlightPlan for Embolization | 2023 | 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 33 years and passes through 5 companies; a new generation was cleared every 8.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K223490 (GE Medical Systems SCS, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121200.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193261: FlightPlan for Embolization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193261
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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