510(k) · Cleared
ClearedCT Rembra RT; CT Areta RT; CT Rembra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare (Suzhou) Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 23, 2026 as substantially equivalent to K232491 (Philips Healthcare (Suzhou) Co., Ltd., 2024) and 2 other predicates after a 186-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Mar 23, 2026
- Review
- 186 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K930090 (1993). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK930090 HelicatElscint, Inc. · 1993
- 8 generations between
- 3 generations backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- 2 generations backK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- 1 generation backK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- This deviceK252992 CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK930090 HelicatElscint, Inc. · 1993
- 11 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 10 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 9 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 8 generations backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- 7 generations backK060937 Brilliance VolumePhilips Medical Systems (Cleveland), Inc. · 2006 · Recalled
- 6 generations backK131773 Brilliance IctPhilips Healthcare (Cleveland) · 2013
- 5 generations backK133674 Philips Iqon Spectral CTPhilips Healthcare (Cleveland) · 2014 · Recalled
- 4 generations backK163711 IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 2017 · Recalled
- 3 generations backK193454 IQon Spectral CTPhilips Medical Systems Nederland B.V. · 2020 · Recalled
- 2 generations backK203020 Spectral CTPhilips Medical Systems Nederland B.V. · 2021 · Recalled
- 1 generation backK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- This deviceK252992 CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −11 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −10 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −9 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −8 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| −7 | K060937 | Brilliance Volume | Philips Medical Systems (Cleveland), Inc. | 2006 | 61 |
| −6 | K131773 | Brilliance Ict | Philips Healthcare (Cleveland) | 2013 | — |
| −5 | K133674 | Philips Iqon Spectral CT | Philips Healthcare (Cleveland) | 2014 | 6 |
| −4 | K163711 | IQon Spectral CT | Philips Medical Systems (Cleveland), Inc. | 2017 | 2 |
| −3 | K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020 | 6 |
| −2 | K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 | 8 |
| −1 | K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies, Ltd. | 2024 | — |
| 0 (this device) | K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K232491 | CT 5300Summary page 5…rade Name: CT 5300 Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K232491 Classification Regulation: 21 CFR 892.1750 1… | 2024 |
| * | K171850 | Philips CT Big BoreSummary page 6…Name: Philips CT Big Bore Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K171850 Classification Regulation: 21 CFR 892.1750 Classification Name: Computed tomography x-ray system C… | 2017 |
| * | K240844 | Spectral CT 7500 RTSummary page 6…Name: Spectral CT 7500 RT Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K240844 Classification Regulation: 21 CFR 892.1750 Classification Name: Computed tomography x-ray system C… | 2024 |
| † | K242329 | CT Collaboration Live | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 16 of the 24 ancestors have a recall of any class.
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. 2026, 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 proposed CT Rembra RT, CT Areta RT, and CT Rembra are Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment support, components and accessories. The system is indicated for diagnostic imaging in radiology, head and whole-body X-ray Computed…
Read the full statement (174 words)
The proposed CT Rembra RT, CT Areta RT, and CT Rembra are Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment support, components and accessories. The system is indicated for diagnostic imaging in radiology, head and whole-body X-ray Computed Tomography applications in oncology as part of treatment preparation and radiation therapy planning, vascular, interventional, neurology and cardiology, for patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or a professional medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252992 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252992: CT Rembra RT; CT Areta RT; CT Rembra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252992
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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