510(k) Report

510(k) · Cleared

Cleared

Lung Analysis Software

K151283510(k) TraditionalCleared Oct 30, 2015169-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vital Images, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Oct 30, 2015 as substantially equivalent to K043333 (Vital Images, Inc., 2004) after a 169-day review. Its family tree reaches back 7 generations to 1991. 8 later devices descend from it.

Decided
Oct 30, 2015
Review
169 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K913770 (1991). 23 ancestors in all. 8 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors2001: 4 other ancestors2000: 2 other ancestors1997: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors1994: 2 other ancestors2017: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2021: 2 descendants cleared2020: 2 descendants cleared2025: 1 descendant clearedReference device: K033374 · Lungcare CT Software Package with Extended Functionality · Siemens AG Medical Solutions · 2003K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002×2: 2 generations cleared close together, K032748 (2003), K040305 (2004) K043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 6 other ancestors4 generations back: 5 other ancestors5 generations back: 3 other ancestors6 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 1 descendant K043333 · VITREA2, Version 3.7 Medical Image Processing System · Vital Images, Inc. · 2004 · recalledK040305 · VITREA2 Version 3.5 · Vital Images, Inc. · 2004K032748 · VITREA2, Version 3.4 Medical Image Processing Software · Vital Images, Inc. · 2003 · recalledK023003 · Imagechecker-CT Workstation · R2 Technology, Inc. · 2002K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991−50
  1. Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. 4 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
  5. 3 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
  6. 2 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
  7. 1 generation backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
  8. This deviceK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
  9. Descendant · cites it directly · 7 of its ownK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
  10. Descendant · 2 generations on · 1 of its ownK202990 NinesMeasureNines, Inc. · 2021
  11. Descendant · 2 generations on · 1 of its ownK193220 Aview LCSCoreline Soft Co., Ltd. · 2020
  12. Descendant · 2 generations on · 0 of its ownK240554 InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025
  13. Descendant · 2 generations on · 0 of its ownK240740 qCT LN QuantQure.Ai Technologies · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2017: 12020: 22021: 22022: 12024: 12025: 1
2017high 2 (2020) · low 0 (2018)2026

Most influential descendants

Showing 5 of 8 · See all
  • K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017 · cites it directly7descendants
  • K202990NinesMeasureNines, Inc. · 2021 · 2 generations on1descendant
  • K193220Aview LCSCoreline Soft Co., Ltd. · 2020 · 2 generations on1descendant
  • K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
  • K240740qCT LN QuantQure.Ai Technologies · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−6K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−5K020483Advantage Workstation 4.1GE Medical Systems20022
−4K023003Imagechecker-CT WorkstationR2 Technology, Inc.2002—
−3K032748VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc.20032
−2K040305VITREA2 Version 3.5Vital Images, Inc.2004—
−1K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041
0 (this device)K151283Lung Analysis SoftwareVital Images, Inc.2015—
+1K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.2017—
+2K202990NinesMeasureNines, Inc.2021—
+2K193220Aview LCSCoreline Soft Co., Ltd.2020—
+2K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.2025—
+2K240740qCT LN QuantQure.Ai Technologies2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199620
199710
199820
199910
200020
200140
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202020
202120
202210
202410
202510
FIG. 1 — Lineage of K151283, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K043333VITREA2, Version 3.7 Medical Image Processing System
Summary page 5
…dicate Device: Predicate Device Manufacturer FDA 510(k) number Lung Analysis Vital Images, Inc. K043333 (Legally Marketed Device) Reference Device: Reference Device Manufacturer FDA 510(k) num…
Vital Images, Inc.20041
†K033374Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions2003—

Also cleared against K043333: 4 other devices →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177

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 24 years and passes through 4 companies; a new generation was cleared every 11 months on median.
  • 5 of the 23 ancestors have a recall of any class.
  • Of its descendants, K162484 (Philips Medical Systems Nederland B.V., 2017) has gone furthest, with 7 descendants of its own.
  • 4 other devices also cite its predicate K043333.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

What is it indicated for?

The separately-licensed Lung Analysis option is intended for the review and analysis of thoracic CT images for the purposes of characterizing nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules and measurements to be displayed.

Indications for use as stated in the FDA summary.

Also cleared against K043333

4 other devices cite the same predicate.

  • K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc. · 2014
  • K111758Cadens (TM) ColonDog Microsystems, Inc. · 2012
  • K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 20052 recalls
  • K052963Mediq Version 1.0Clario Medical Imaging, Inc. · 2005

More from Vital Images, Inc.

41 FDA decisions under this applicant name. See the company

  • K181247Vitrea CT Brain PerfusionVital Images, Inc. · 2018
  • K182230Multi Modality ViewerVital Images, Inc. · 2018
  • K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc. · 2017
  • K163232Vitrea ViewVital Images, Inc. · 2017
  • K163574Multi Modality ViewerVital Images, Inc. · 2017

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K151283 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151283: Lung Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151283

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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