510(k) · Cleared
ClearedLung Volume Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Aug 17, 2012 as substantially equivalent to K071513 (Siemens Medical Solutions, 2007) after a 242-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Aug 17, 2012
- Review
- 242 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954355 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 5 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 4 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 3 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 2 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 1 generation backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- This deviceK113715 Lung Volume AnalysisToshibamedical Systems Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −5 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −4 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −3 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −2 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −1 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| 0 (this device) | K113715 | Lung Volume Analysis | Toshibamedical Systems Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 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? (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 |
|---|---|---|---|
| * | K071513 | Inspace 4D Software Package with Extended FunctionalitySummary page 1…rmance Standard: None Predicate Device(s): Siemens Healthcare; InSpace 4D (InSpace Lung Parenchyma), k071513 Reason for Submission New Device Description of this Device: The CSLV-OOLA, Lung Volume Analysis is a post-pro… | 2007 |
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 17 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 4 other devices also cite its predicate K071513.
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. 2012, 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 Lung Volume Analysis can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D3 segmentation & isolation of subcompartments, volumetric analysis) and reporting tools are combined with a dedicated workflow. This software application can be Used with standard non-contrast-enhanced chest volume acquisitions.
When used by a qualified physician, a potential application is to determine the course of treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113715: Lung Volume Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113715
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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