510(k) · Cleared
ClearedAdvanced Lung Analysis-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 26, 2001 as substantially equivalent to K963345 (GE Medical Systems, 1996) after a 14-day review. Its family tree reaches back 2 generations to 1991. 1 of the 473 devices in its family, counting itself, has a Class I recall. 470 later devices descend from it.
- Decided
- Oct 26, 2001
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913770 (1991). 470 later devices descend from it, 7 citing it directly. 1 of the 473 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 1 generation backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- This deviceK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- Descendant · cites it directly · 379 of its ownK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- Descendant · 2 generations on · 295 of its ownK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- Descendant · 2 generations on · 263 of its ownK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- Descendant · 3 generations on · 222 of its ownK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 4 generations on · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
Showing 5 of 470 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 470 · See all- K022013Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002 · cites it directly379descendants
- K033374Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003 · 2 generations on295descendants
- K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007 · 2 generations on263descendants
- K041484UndecidedSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on222descendants
- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · 4 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −1 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| 0 (this device) | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| +1 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +2 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| +2 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| +3 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 11 | 0 |
| 2012 | 23 | 0 |
| 2013 | 11 | 0 |
| 2014 | 19 | 0 |
| 2015 | 20 | 0 |
| 2016 | 16 | 0 |
| 2017 | 21 | 0 |
| 2018 | 27 | 0 |
| 2019 | 22 | 0 |
| 2020 | 31 | 0 |
| 2021 | 25 | 0 |
| 2022 | 34 | 0 |
| 2023 | 33 | 0 |
| 2024 | 35 | 0 |
| 2025 | 44 | 1 |
| 2026 | 38 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K963345 | Advantage Windows Tissue Volume OptionSummary page 1…anced Lung Analysis is substantially equivalent to the device listed below: Model: Tissue Volume Manufacturer: General Electric Medical Systems, Milwaukee, W1 510(k) #: K963345 Device Description: Advanced Lung Analysis-1 (ALA-1) is an image analysis software package that provides support to the medical… | 1996 |
What descends from it? (470)
See all 4707 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K022013 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 379 descendants of its own.
- 2 other devices also cite its predicate K963345.
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.
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?
Advanced Lung Analysis (ALA-I) is intended to provide an optimized non-invasive application to
measure abnormalities in the lung (for example, nodules, lesions etc.) from a set of computed
tomography (CT) images. The analysis is performed on the Advantage Windows Workstation
(K913770). The software allows measurement of volume over time using a consistent
standardized measurement protocol, thus providing an estimation of the volume doubling time.
This may aid the physician in characterization of suspicious nodules and thus, patient
management care decision process.
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/K013381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013381: Advanced Lung Analysis-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013381
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026