510(k) · Cleared
ClearedXV Lung Ventilation Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
4Dx Limited · JAK System, X-Ray, Tomography, Computed
Cleared on May 14, 2020 as substantially equivalent to K151919 (Vital Images, Inc., 2015) and 1 other predicate after a 169-day review. Its family tree reaches back 11 generations to 1980.
- Decided
- May 14, 2020
- Review
- 169 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K801623 (1980). 58 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations between
- 3 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- 1 generation backK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018 · Recalled
- This deviceK193293 XV Lung Ventilation Analysis Software4Dx Limited · 2020
Show all 11 generations
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 9 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 8 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 7 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 6 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 4 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 3 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- 1 generation backK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018 · Recalled
- This deviceK193293 XV Lung Ventilation Analysis Software4Dx Limited · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −10 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −9 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −8 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −7 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −6 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −5 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −4 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −3 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −2 | K141574 | Artis Zee/Zeego SW VC21 | Siemens Medical Solutions USA, Inc. | 2014 | 12 |
| −1 | K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | 2018 | 59 |
| 0 (this device) | K193293 | XV Lung Ventilation Analysis Software | 4Dx Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 11 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K151919 | Vitrea CT Lung Density Analysis SoftwareSummary page 4…Tomography X-ray System Class II Classification Class: JAK Product Code: 3. Legally Marketed Primary Predicate Device Predicate 510(k) number: K151919 Name of Device: Vitra CT Lung Density Analysis Software Manufacturer: Vital Images, Inc.… | 2015 |
| * | K181407 | Artis zee/zeego & Artis Q/Q.zenSummary page 4…ass II Product Code: JAK Decision Date: 10/10/2015 4. Legally Marketed Secondary Predicate Device Predicate 510(k) number: K181407 Name of Device: Artis zee/zeego & Artis Q/Q.zen Manufacturer: Siemens Medical Solution USA, I… | 2018 |
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 40 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 13 of the 58 ancestors have a recall of any class.
- 2 other devices also cite its predicate K151919.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient’s present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients. The XV Ventilation Lung Analysis Software provides reproducible quantification of ventilation for pulmonary tissue, which is essential for providing…
Read the full statement (251 words)
The XV Ventilation Lung Analysis Software is software-based image processing technology that analyzes cinefluorograph images and a CT (can be a previously acquired CT that is representative of the patient’s present lung envelope), to quantify ventilation of pulmonary tissue for use in adult patients.
The XV Ventilation Lung Analysis Software provides reproducible quantification of ventilation for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. For use by referral from a pulmonary specialist or equivalent, the Device can be used to provide the physician with additional clinical data in the diagnosis and documentation of inhomogeneities and defects in pulmonary ventilation. Quantification and statistics are provided in the form of a Report, including:
• The tidal volume (i.e. total lung ventilation), presented as a single value;
• Visualization of lung ventilation with color-defined specific ventilation ranges overlaid on the CT slices;
• The heterogeneity of lung ventilation, presented as three values, which quantifies the regional variability of the ventilation; and
• Ventilation graph/ histogram of the classified lung voxel’s relative frequencies showing the frequency distribution of regional specific ventilation measured across the entire lung, including ventilation defect percentage which shows the volume of lung with low ventilation.
The clinical study used to validate the Device was limited to patients selected to undergo Radiation Therapy (most commonly for breast cancer and esophageal cancer). In this study these patients were examined using the Device at four time-points over a 13-month period (twice prior and twice following radiation therapy).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193293 · printed Nov 3, 2026
Cite this page
510(k) Report. “K193293: XV Lung Ventilation Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K193293
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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