510(k) · Cleared
ClearedSpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arineta, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 15, 2025 as substantially equivalent to K241200 (Arineta, Ltd., 2025) after a 42-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Apr 15, 2025
- Review
- 42 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K013561 (2001). No later device cites it as a predicate yet.
- Root · 11 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 7 generations between
- 3 generations backK213465 CardioGrapheArineta, Ltd. · 2022
- 2 generations backK230370 SpotLight/SpotLight Duo (with DLIR option)Arineta, Ltd. · 2023
- 1 generation backK241200 SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd. · 2025
- This deviceK250650 SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 10 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 9 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 8 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 7 generations backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- 6 generations backK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
- 5 generations backK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
- 4 generations backK161066 SpotLight CTArineta, Ltd. · 2016
- 3 generations backK213465 CardioGrapheArineta, Ltd. · 2022
- 2 generations backK230370 SpotLight/SpotLight Duo (with DLIR option)Arineta, Ltd. · 2023
- 1 generation backK241200 SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd. · 2025
- This deviceK250650 SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −10 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −9 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −8 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −7 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| −6 | K120833 | Discovery CT750 HD | Ge Medical Systems, LLC | 2012 | 1 |
| −5 | K133705 | Revolution CT | Ge Medical Systems, LLC | 2014 | 14 |
| −4 | K161066 | SpotLight CT | Arineta, Ltd. | 2016 | — |
| −3 | K213465 | CardioGraphe | Arineta, Ltd. | 2022 | — |
| −2 | K230370 | SpotLight/SpotLight Duo (with DLIR option) | Arineta, Ltd. | 2023 | — |
| −1 | K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta, Ltd. | 2025 | — |
| 0 (this device) | K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta, Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionSummary page 5…ode(s): JAK III. PREDICATE DEVICE Predicate Device Name: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option Manufacturer: Arineta Ltd. 510(k) Number: K241200 Common Name: System, X-ray, Tomography, Computed Classification Name: Computed tomography x-ray system Regulation Number: 892.175… | 2025 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 11 ancestors have a recall of any class.
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. 2025, 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 SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2…
Read the full statement (290 words)
The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.
The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.
The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.
The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250650: SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250650
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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