510(k) · Cleared
ClearedBrilliance Ict
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare (Cleveland) · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 24, 2013 as substantially equivalent to K060937 (Philips Medical Systems (Cleveland), Inc., 2006) after a 99-day review. Its family tree reaches back 6 generations to 1993. 11 later devices descend from it.
- Decided
- Sep 24, 2013
- Review
- 99 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930090 (1993). 11 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK930090 HelicatElscint, Inc. · 1993
- 5 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 4 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 3 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 1 generation backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- This deviceK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- Descendant · cites it directly · 10 of its ownK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- Descendant · 2 generations on · 7 of its ownK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- Descendant · 3 generations on · 6 of its ownK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- Descendant · 4 generations on · 5 of its ownK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- Descendant · 5 generations on · 3 of its ownK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K133674Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · cites it directly10descendants
- K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · 2 generations on7descendants
- K193454IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · 3 generations on6descendants
- K203020Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · 4 generations on5descendants
- K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −5 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −4 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −3 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −2 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −1 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| 0 (this device) | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| +1 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| +2 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 2 |
| +3 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 |
| +4 | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | 8 |
| +5 | K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K060937 | Brilliance VolumeSummary page 2…s claimed: Device Name 510 k)No. Date of Clearance Brilliance Volume K060937 June 5, 2006 Compliance with Standards: Brilliance iCT complies with the following standards:… | 2006 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133674 | Philips Iqon Spectral CT | 2014 | 10 |
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 20 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K133674 (Philips Healthcare (Cleveland), 2014) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K060937.
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 "Brilliance iCT" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components, and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131773 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131773: Brilliance Ict.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131773
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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