510(k) · Cleared
ClearedASIR-V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 25, 2014 as substantially equivalent to K103489 (General Electric Co., 2011) and 1 other predicate after a 118-day review. Its family tree reaches back 6 generations to 2001. 9 later devices descend from it.
- Decided
- Mar 25, 2014
- Review
- 118 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K013561 (2001). 9 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 5 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 4 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 3 generations backK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- 2 generations backK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- 1 generation backK103489 GE Veo Reconstruction OptionGeneral Electric Co. · 2011
- This deviceK133640 ASIR-VGe Medical Systems, LLC · 2014
- Descendant · cites it directly · 8 of its ownK183202 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK213999 Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK193170 Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019
- Descendant · 3 generations on · 0 of its ownK253686 True Definition DLGe Healthcare Japan Corporation · 2026
- Descendant · 3 generations on · 0 of its ownK230807 Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K183202Deep Learning Image ReconstructionGe Medical Systems, LLC · 2019 · cites it directly8descendants
- K213999Deep Learning Image ReconstructionGe Medical Systems, LLC · 2022 · 2 generations on2descendants
- K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2019 · 2 generations on1descendant
- K253686True Definition DLGe Healthcare Japan Corporation · 2026 · 3 generations on0descendants
- K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −5 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −4 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −3 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| −2 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| −1 | K103489 | GE Veo Reconstruction Option | General Electric Co. | 2011 | — |
| 0 (this device) | K133640 | ASIR-V | Ge Medical Systems, LLC | 2014 | — |
| +1 | K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019 | — |
| +2 | K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022 | — |
| +2 | K193170 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2019 | — |
| +3 | K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026 | — |
| +3 | K230807 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K103489 | GE Veo Reconstruction OptionSummary page 1…-ray System Classification Names: Computed Tomography X-ray System per 21CFR 892.1750 Product Code: 90-JAK Predicate Device K1 03489 - Veo Reconstruct option K093581 - Discovery CT590/Optima CT580 (includes a r… | 2011 |
| * | K093581 | Discovery Model CT590 RT and Optima Model CT580 CT SystemsSummary page 1…ography X-ray System per 21CFR 892.1750 Product Code: 90-JAK Predicate Device K1 03489 - Veo Reconstruct option K093581 - Discovery CT590/Optima CT580 (includes a robust analysis of ASiR) Manufacturer:… | 2011 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183202 | Deep Learning Image Reconstruction | 2019 | 8 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 9 ancestors have a recall of any class.
- Of its descendants, K183202 (Ge Medical Systems, LLC, 2019) has gone furthest, with 8 descendants of its own.
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. 2014, 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 ASiR-V Reconstruction Option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Helical (Volumetric), and Cardiac acquisitions for all ages. When used, it allows for an alternate reconstruction method designed to reduce image noise and streak artifact, increase resolution and improve low contrast detectability in images…
Read the full statement (142 words)
The ASiR-V Reconstruction Option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Helical (Volumetric), and Cardiac acquisitions for all ages.
When used, it allows for an alternate reconstruction method designed to reduce image noise and streak artifact, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from the GE CT scanner. The ASiR-V Reconstruction Option can be used to reduce noise in images and also to reduce the dose required for diagnostic CT imaging, including scans of the head, chest, heart, abdomen and pelvis. The ASiR-V Reconstruction Option may also improve the image quality of low dose non-diagnostic Filtered Back Projection images such that they become diagnostic.
ASiR-V reconstruction option is for use with the GE CT Scanners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133640 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133640: ASIR-V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133640
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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