510(k) · Cleared
ClearedLung Vision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bodyvision Medical, Ltd. · LLZ System, Image Processing, Radiological
Cleared on May 11, 2017 as substantially equivalent to K062650 (Philips Medical Systems, 2006) after a 140-day review. Its family tree reaches back 7 generations to 1989. 6 later devices descend from it.
- Decided
- May 11, 2017
- Review
- 140 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K890348 (1989). 37 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 6 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 5 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
- 4 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
- 3 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
- 2 generations backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
- 1 generation backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- This deviceK163622 Lung VisionBodyvision Medical, Ltd. · 2017
- Descendant · cites it directly · 5 of its ownK172418 OpenSightNovarad Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK221796 Cyware 4H and Cysart 4HAbys Medical · 2022
- Descendant · 2 generations on · 1 of its ownK213128 IntraOp VSP Software DeviceXironetic, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK243069 Lumys (V1)Intradys · 2025
- Descendant · 3 generations on · 0 of its ownK232189 OrionXRHoth Intelligence, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172418OpenSightNovarad Corporation · 2018 · cites it directly5descendants
- K221796Cyware 4H and Cysart 4HAbys Medical · 2022 · 2 generations on1descendant
- K213128IntraOp VSP Software DeviceXironetic, LLC · 2022 · 2 generations on1descendant
- K243069Lumys (V1)Intradys · 2025 · 3 generations on0descendants
- K232189OrionXRHoth Intelligence, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −6 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −5 | K020055 | Philips Integris Allura 9 with FD Option | Philips Medical Systems | 2002 | 2 |
| −4 | K022899 | Philips Integris Allura Flat Detector Release 1.0 | Philips Medical Systems North America Co. | 2002 | 8 |
| −3 | K031333 | Philips Integris Allura Flat Detector Release 1.2 | Philips Medical Systems North America, Inc. | 2003 | 25 |
| −2 | K031836 | Philips Fresco Release 1 | Philips Medical Systems North America Co. | 2003 | — |
| −1 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| 0 (this device) | K163622 | Lung Vision | Bodyvision Medical, Ltd. | 2017 | — |
| +1 | K172418 | OpenSight | Novarad Corporation | 2018 | — |
| +2 | K221796 | Cyware 4H and Cysart 4H | Abys Medical | 2022 | — |
| +2 | K213128 | IntraOp VSP Software Device | Xironetic, LLC | 2022 | — |
| +3 | K243069 | Lumys (V1) | Intradys | 2025 | — |
| +3 | K232189 | OrionXR | Hoth Intelligence, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K062650 | EP Navigator SoftwareSummary page 4…ure archiving and communications system LLZ, Class II, CFR 892.2050 Predicate Device: Philips EP-Navigator K062650 Device Description: The LungVision System is designed enabling users to segment previously acquired 3D CT datasets and overlay a… | 2006 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172418 | OpenSight | 2018 | 5 |
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 28 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 37 ancestors have a recall of any class.
- Of its descendants, K172418 (Novarad Corporation, 2018) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K062650.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray images of the same anatomy in order to support catheter/device navigation during pulmonary procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163622: Lung Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163622
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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