510(k) · Cleared
ClearedPrimelung
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuimage Diagnostics Corp. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 21, 2003 as substantially equivalent to K022013 (Siemens Medical Solutions USA, Inc., 2002) and 2 other predicates after a 67-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Feb 21, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945188 (1995). 14 ancestors in all, the oldest K864854 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 3 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 2 generations backK982535 Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998
- 1 generation backK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
- This deviceK024149 PrimelungAccuimage Diagnostics Corp. · 2003
- Descendant · cites it directly · 0 of its ownK070868 LMS-Lung/TrackMedian Technologies · 2007
Most influential descendants
Showing 1 of 1 · See all- K070868LMS-Lung/TrackMedian Technologies · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −3 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −2 | K982535 | Insight Diagnostic Imaging Workstation | Neo Imagery Technologies, Inc. | 1998 | — |
| −1 | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze… | Accuimage Diagnostics Corp. | 1999 | — |
| 0 (this device) | K024149 | Primelung | Accuimage Diagnostics Corp. | 2003 | — |
| +1 | K070868 | LMS-Lung/Track | Median Technologies | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (3)
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 |
|---|---|---|---|
| * | K022013 | Lungcare CT Software Package | 2002 |
| * | K013381 | Advanced Lung Analysis-1 | 2001 |
| * | K990241 | Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope…Summary page 1…ware module. Device Description: The Acculmage PrimeLung software module is an additional software option to K990241,AccuView Diagnostics Imaging Workstation with AccuScore,… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070868 | LMS-Lung/Track | 2007 | 0 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K070868 (Median Technologies, 2007) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K022013.
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?
Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024149: Primelung.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024149
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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