510(k) · Cleared
ClearedStereo 3D option for Vision Applications
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 20, 2016 as substantially equivalent to K092639 (GE Medical Systems SCS, 2009) and 1 other predicate after a 153-day review. Its family tree reaches back 6 generations to 1989. 1 later device descends from it.
- Decided
- Jan 20, 2016
- Review
- 153 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K890348 (1989). 27 ancestors in all, the oldest K852353 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 5 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 4 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 2 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 1 generation backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- This deviceK152352 Stereo 3D option for Vision ApplicationsGE Medical Systems SCS · 2016
- Descendant · cites it directly · 0 of its ownK223152 Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS · 2022
Most influential descendants
Showing 1 of 1 · See all- K223152Vision 2, EVARVision, TrackVision 2, HeartVision 2GE Medical Systems SCS · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −5 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −4 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −3 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −2 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −1 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| 0 (this device) | K152352 | Stereo 3D option for Vision Applications | GE Medical Systems SCS | 2016 | — |
| +1 | K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | GE Medical Systems SCS | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…Summary page 5…Class: II Page 5 - 2 GE Healthcare 510(k) Premarket Notification Submission Primary Predicate K092639, Innova Vision Applications (from GE Healthcare) Device(s): Product code: LLZ; Regulation numb… | 2009 |
| * | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQSummary page 5…2639, Innova Vision Applications (from GE Healthcare) Device(s): Product code: LLZ; Regulation number: 892.2050. Second Predicate K052412, Innova 3D (from GE Healthcare) Device(s): Product code: OWB, JAA; Regulation number : 892.165… | 2005 |
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 |
|---|---|---|---|
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | 2022 | 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 27 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 16 of the 27 ancestors have a recall of any class.
- Of its descendants, K223152 (GE Medical Systems SCS, 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K092639.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Vision 2, TrackVision 2 and HeartVision 2 software applications are 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.
The Stereo 3D option enables physicians to visualize and localize needles, points, and segments on a 3D model/space using a stereotactic reconstruction of radioscopic or radiographic images at a significantly lower dose than use of a full cone beam CT acquisition. This information is intended to assist the physician during interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152352: Stereo 3D option for Vision Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152352
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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