510(k) · Cleared
ClearedLightspeed 2.0CT Scanner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 15, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 50 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it.
- Decided
- Feb 15, 2000
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 4 citing it directly. 6 of the 50 devices in this family, counting this one, have a Class I recall.
- This deviceK000300 Lightspeed 2.0CT Scanner SystemGe Medical Systems, Inc. · 2000
- Descendant · cites it directly · 27 of its ownK051765 Ceretom, Model NL3000Neurologica Corporation · 2005
- Descendant · cites it directly · 17 of its ownK052855 Starspeed Series CT Scanner SystemsGE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 16 of its ownK082816 GE Brightspeed Delight CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
- Descendant · 3 generations on · 13 of its ownK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K051765Ceretom, Model NL3000Neurologica Corporation · 2005 · cites it directly27descendants
- K052855Starspeed Series CT Scanner SystemsGE Healthcare · 2005 · cites it directly17descendants
- K082816GE Brightspeed Delight CT Scanner SystemGe Medical Systems, LLC · 2008 · 2 generations on16descendants
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 3 generations on13descendants
- K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000300 | Lightspeed 2.0CT Scanner System | Ge Medical Systems, Inc. | 2000 | — |
| +1 | K051765 | Ceretom, Model NL3000 | Neurologica Corporation | 2005 | — |
| +1 | K052855 | Starspeed Series CT Scanner Systems | GE Healthcare | 2005 | 5 |
| +2 | K082816 | GE Brightspeed Delight CT Scanner System | Ge Medical Systems, LLC | 2008 | 9 |
| +3 | K093514 | Discovery Model NM/CT 670 | Ge Medical Systems F.I. Haifa | 2009 | Class I |
| +2 | K090811 | Inspira HD, Model: NL1000 | Neurologica Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2011 | 3 | 2 |
| 2012 | 1 | 1 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 1 |
| 2017 | 4 | 0 |
| 2018 | 4 | 1 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (49)
See all 494 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K111445Discovery NM 630GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113350Brivo NM 615GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121019Optima NM/CT 640GE Healthcare · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K051765 (Neurologica Corporation, 2005) has gone furthest, with 27 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.
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 | — |
https://510kreport.com/device/K000300 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000300: Lightspeed 2.0CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000300
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026