510(k) · Cleared
Recalled · Class II · 2024Optima CT660
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 Aug 30, 2013 as substantially equivalent to K110227 (Ge Medical Systems, LLC, 2011) after a 91-day review. Its family tree reaches back 6 generations to 2001. 5 later devices descend from it. It has been recalled 8 times.
- Decided
- Aug 30, 2013
- Review
- 91 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013561 (2001). 5 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 backK082761 GE Lightspeed 7.2 CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
- 1 generation backK110227 Optima CT660Ge Medical Systems, LLC · 2011 · Recalled
- This deviceK131576 Optima CT660Ge Medical Systems, LLC · 2013
- Descendant · cites it directly · 4 of its ownK192686 Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019 · Recalled
- Descendant · 2 generations on · 3 of its ownK203169 Revolution AscendGe Healthcare Japan Corporation · 2020 · Recalled
- Descendant · 3 generations on · 2 of its ownK213938 Revolution AscendGe Healthcare Japan Corporation · 2022 · Recalled
- Descendant · 4 generations on · 0 of its ownK233698 True Enhance DLGe Healthcare Japan Corporation · 2024
- Descendant · 4 generations on · 0 of its ownK233749 Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K192686Revolution Maxima, Revolution AceGe Hangwei Medical Systems Co., Ltd. · 2019 · cites it directly4descendants
- K203169Revolution AscendGe Healthcare Japan Corporation · 2020 · 2 generations on3descendants
- K213938Revolution AscendGe Healthcare Japan Corporation · 2022 · 3 generations on2descendants
- K233698True Enhance DLGe Healthcare Japan Corporation · 2024 · 4 generations on0descendants
- K233749Revolution Ascend SlidingGe Hangwei Medical Systems Co., Ltd. · 2024 · 4 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 | K082761 | GE Lightspeed 7.2 CT Scanner System | Ge Medical Systems, LLC | 2008 | 3 |
| −1 | K110227 | Optima CT660 | Ge Medical Systems, LLC | 2011 | 5 |
| 0 (this device) | K131576 | Optima CT660 | Ge Medical Systems, LLC | 2013 | — |
| +1 | K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | 2019 | 5 |
| +2 | K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | 2020 | 1 |
| +3 | K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022 | 2 |
| +4 | K233698 | True Enhance DL | Ge Healthcare Japan Corporation | 2024 | — |
| +4 | K233749 | Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K110227 | Optima CT660Summary page 2…1/6 GE Healthcare 510(k) Premarket Notification Submission for Optima CT660 v2 Predicate Device K1 10227 - Optima CT66O Manufacturer: GE Healthcare Japan Corporation /Design Location: 7-127 Asahigaolka, 4-chome… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192686 | Revolution Maxima, Revolution Ace | 2019 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2024 | Class II | Z-0608-2025 | Component design/selection | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if… |
| Jun 14, 2021 | Class II | Z-1900-2021 | Radiation Control for Health and Safety Act | Improperly loaded software options may result in additional X -ray radiation exposure to the patient. |
| May 24, 2018 | Class II | Z-2584-2018 | Component change control | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). |
| May 24, 2018 | Class II | Z-2583-2018 | Component change control | Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply). |
| Apr 27, 2018 | Class II | Z-2873-2018 | Employee error | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. |
| Apr 27, 2018 | Class II | Z-2870-2018 | Employee error | GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry. |
| May 19, 2017 | Class II | Z-2181-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
| May 19, 2017 | Class II | Z-2182-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 6 ancestors have a recall of any class.
- Of its descendants, K192686 (Ge Hangwei Medical Systems Co., Ltd., 2019) has gone furthest, with 4 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. 2013, 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 Optima CT660 is intended to produce crass-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. 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…
Read the full statement (137 words)
The Optima CT660 is intended to produce crass-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. 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 transaxial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.
The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.
The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131576: Optima CT660.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131576
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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