510(k) · Cleared
Recalled · Class II · 2017Lightspeed 7.0 CT Scanner System
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 1, 2004 as substantially equivalent to K030420 (GE Medical Systems, 2003) after a 13-day review. Its family tree reaches back 2 generations to 2001. 86 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 1, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013561 (2001). 86 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 1 generation backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- This deviceK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004
- Descendant · cites it directly · 45 of its ownK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
- Descendant · cites it directly · 38 of its ownK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 36 of its ownK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- Descendant · 2 generations on · 35 of its ownK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
- Descendant · 3 generations on · 32 of its ownK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K061817Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · cites it directly45descendants
- K052216Somatom DefinitionSiemens Medical Systems, Inc. · 2005 · cites it directly38descendants
- K082220Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on36descendants
- K081105GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · 2 generations on35descendants
- K113342Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −1 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| 0 (this device) | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | — |
| +1 | K061817 | Lightspeed 7.1 CT Scanner System | Ge Medical Systems, LLC | 2006 | 1 |
| +1 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| +2 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +2 | K081105 | GE Lightspeed CT750 HD (Lightspeed 8.0) | GE Healthcare | 2008 | 5 |
| +3 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K030420 | Lightspeed 5.0 Computed Tomography SystemSummary page 1…s image acquisition hardware, image acquisition and reconstruction software, and associated accessories. LightSpeed 7.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indica… | 2003 |
What descends from it? (86)
See all 864 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2017 | Class II | Z-2183-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
| Jul 25, 2011 | Class II | Z-1188-2013 | Process control | Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking… |
| Dec 21, 2006 | Not classified | Z-0803-2007 | Other | Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis. |
| Dec 21, 2006 | Not classified | Z-0802-2007 | Other | Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis. |
| Dec 8, 2006 | Not classified | Z-0507-2007 | Other | When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be introduced. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K061817 (Ge Medical Systems, LLC, 2006) has gone furthest, with 45 descendants of its own.
- 5 other devices also cite its predicate K030420.
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?
The LightSpeed 7.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040372: Lightspeed 7.0 CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040372
Report an extraction error
Are you the manufacturer?
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