510(k) · Cleared
ClearedAI-Rad Companion (Pulmonary)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jul 26, 2019 as substantially equivalent to K123540 (Siemens Medical Systems, Inc., 2013) and 1 other predicate after a 245-day review. Its family tree reaches back 10 generations to 1991. 6 later devices descend from it.
- Decided
- Jul 26, 2019
- Review
- 245 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 137 ancestors in all, the oldest K871859 (1987). 6 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK183271 AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK203699 syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK213713 AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK214019 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK233753 AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · 2024
- Descendant · 3 generations on · 0 of its ownK221727 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK183271 AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021 · cites it directly3descendants
- K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · 2022 · cites it directly1descendant
- K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022 · 2 generations on1descendant
- K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH · 2024 · 2 generations on0descendants
- K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| 0 (this device) | K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +1 | K203699 | syngo. CT Extended Functionalities | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +1 | K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2022 | — |
| +2 | K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +2 | K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2024 | — |
| +3 | K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 5 | 0 |
| 2004 | 12 | 0 |
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K123540 | Syngo CT Pulmo 3DSummary page 4…y Predicate Device: Product Name: syngo.CT Pulmo 3D Propriety Trade Name: syngo.CT Pulmo 3D 510(k) Number: K123540 Clearance Date: August 29, 2013 Classification Name: Computed Tomography X-Ray System Seco… | 2013 |
| * | K093621 | Syngo.Pet&CT OncologySummary page 5…Device: Product Name: syngo.PET&CT Oncology Propriety Trade Name: syngo.PET&CT Oncology 510(k) Number: K093621 Clearance Date: February 23, 2010 Classification Name: Picture Archiving and Communicati… | 2010 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 28 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 33 of the 137 ancestors have a recall of any class.
- Of its descendants, K203699 (Siemens Medical Solutions USA, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K123540.
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. 2019, 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?
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality: • Segmentation and measurements of complete lung and lung lobes •…
Read the full statement (142 words)
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of disease of the lungs.
It provides the following functionality:
• Segmentation and measurements of complete lung and lung lobes
• Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes
• Providing an interface to external Medical Device syngo.CT Lung CAD
• Segmentation and measurements of found lung lesions and dedication to corresponding lung lobe.
The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction).
Only DICOM images of adult patients are considered to be valid input.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183271: AI-Rad Companion (Pulmonary).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183271
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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