510(k) · Cleared
Recalled · Class II · 2019Brilliance CT, Private Practice CV Configuration, CT Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 8, 2004 as substantially equivalent to K033326 (Philips Medical Systems, Inc., 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 1993. 147 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930090 (1993). 10 ancestors in all. 147 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
- 4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- This deviceK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004
- Descendant · cites it directly · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013
- Descendant · 2 generations on · 91 of its ownK132165 Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · cites it directly · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · 3 generations on · 45 of its ownK171314 QLAB Advanced Quantification SoftwarePhilips Health Care · 2017
- Descendant · 4 generations on · 44 of its ownK181264 QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018
Showing 5 of 147 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 147 · See all- K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · cites it directly92descendants
- K132165Qlab Quantification SoftwarePhilips Ultrasound, Inc. · 2013 · 2 generations on91descendants
- K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · cites it directly49descendants
- K171314QLAB Advanced Quantification SoftwarePhilips Health Care · 2017 · 3 generations on45descendants
- K181264QLAB Advanced Quantification SoftwarePhilips Ultrasound, Inc. · 2018 · 4 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −4 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −3 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −2 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −1 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| 0 (this device) | K042293 | Brilliance CT, Private Practice CV Configuration, CT Scanner | Philips Medical Systems (Cleveland), Inc. | 2004 | — |
| +1 | K130159 | Qlab Quantification Software Heart Model | Philips Health Care | 2013 | — |
| +2 | K132165 | Qlab Quantification Software | Philips Ultrasound, Inc. | 2013 | 1 |
| +1 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +3 | K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017 | — |
| +4 | K181264 | QLAB Advanced Quantification Software | Philips Ultrasound, Inc. | 2018 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 15 | 0 |
| 2021 | 8 | 0 |
| 2022 | 17 | 0 |
| 2023 | 12 | 0 |
| 2024 | 15 | 0 |
| 2025 | 26 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K033326 | Philips Plus Computed Tomography SystemSummary page 2…is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: * Brilliance CT (Philips Plus, K033326) * Mx8000 IDT, K012009 6. Safety and Effectiveness Considerations The safety of the device is assured by adherence to… | 2003 |
| * | K012009 | MX8000 Idt CT SystemSummary page 2…tantially equivalent to the legally marketed devices currently in commercial distribution, namely: * Brilliance CT (Philips Plus, K033326) * Mx8000 IDT, K012009 6. Safety and Effectiveness Considerations The safety of the device is assured by adherence to GMP practices and to Internati… | 2001 |
What descends from it? (147)
See all 1476 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130159 | Qlab Quantification Software Heart Model | 2013 | 92 |
| K062650 | EP Navigator Software | 2006 | 49 |
| K101311 | EP Navigator R3 | 2010 | 41 |
| K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | 2009 | 19 |
| K112530 | 3DI Including Cscore | 2011 | 1 |
| K051351 | Precedence Spect/CT Imaging System | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2019 | Class II | Z-2191-2019 | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K130159 (Philips Health Care, 2013) has gone furthest, with 92 descendants of its own.
- 8 other devices also cite its predicate K033326.
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 Philips Brilliance CT in the Private Practice CV configuration is a Computed Tomography X-Ray System intended to produce images of the heart, cardiovascular (including pulmonary veins) and peripheral vascular systems (including the carotids, renals, aorta, iliac, and other distal vessels imaged by angiographic run-off procedures) 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/K042293 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042293: Brilliance CT, Private Practice CV Configuration, CT Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042293
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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