510(k) · Cleared
Recalled · Class II · 2025Philips CT Big Bore
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 Nov 9, 2017 as substantially equivalent to K033357 (Philips Medical Systems (Cleveland), Inc., 2004) after a 141-day review. Its family tree reaches back 5 generations to 1993. 6 later devices descend from it. It has been recalled 14 times.
- Decided
- Nov 9, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930090 (1993). 11 ancestors in all. 6 later devices descend from it, 3 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 backK033357 Acqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- This deviceK171850 Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 2017
- Descendant · cites it directly · 3 of its ownK240844 Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK181797 Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253649 Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252992 CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK244008 Spectral CTPhilips Medical Systems Technologies, Ltd. · 2025 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K240844Spectral CT 7500 RTPhilips Medical Systems Technologies, Ltd. · 2024 · cites it directly3descendants
- K181797Philips CT Big Bore Sliding Gantry ConfigurationPhillips Medical Systems (Cleveland), Inc. · 2018 · cites it directly1descendant
- K253649Spectral CT Verida FamilyPhilips Medical Systems Technologies, Ltd. · 2026 · 2 generations on0descendants
- K252992CT Rembra RT; CT Areta RT; CT RembraPhilips Healthcare (Suzhou) Co., Ltd. · 2026 · cites it directly0descendants
- K244008Spectral CTPhilips Medical Systems Technologies, Ltd. · 2025 · 2 generations on0descendants
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 | K033357 | Acqsim-Multislice-CT, Model 453567042271 | Philips Medical Systems (Cleveland), Inc. | 2004 | 50 |
| 0 (this device) | K171850 | Philips CT Big Bore | Philips Medical Systems (Cleveland), Inc. | 2017 | — |
| +1 | K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies, Ltd. | 2024 | — |
| +1 | K181797 | Philips CT Big Bore Sliding Gantry Configuration | Phillips Medical Systems (Cleveland), Inc. | 2018 | — |
| +2 | K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies, Ltd. | 2026 | — |
| +1 | K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026 | — |
| +2 | K244008 | Spectral CT | Philips Medical Systems Technologies, Ltd. | 2025 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K033357 | Acqsim-Multislice-CT, Model 453567042271Summary page 5…Class: II Product Code: JAK Panel: Radiology Primary Predicate device K033357 – AcQSim Multislice CT Scanner Classification Name: Computed Tomography X-ray system… | 2004 |
| † | K160743 | Philips Ingenuity CT | 2016 |
| † | K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | 2016 |
| † | K012238 | Doseright | 2001 |
| † | K023785 | Lung Nodule Assessment and Comparison Option | 2003 |
| † | K020005 | Infant Feeding Tubes | 2002 |
| † | K162025 | IntelliSpace Portal Platform | 2016 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 13, 2025 | Class II | Z-2597-2025 | Process control | The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. |
| Apr 1, 2025 | Class II | Z-1660-2025 | Software design | Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient. |
| Oct 9, 2023 | Class II | Z-0293-2024 | Under Investigation by firm | For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent… |
| Oct 9, 2023 | Class II | Z-0292-2024 | Under Investigation by firm | For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent… |
| Oct 9, 2023 | Class II | Z-0294-2024 | Under Investigation by firm | For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent… |
| Jun 7, 2017 | Class II | Z-0303-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0304-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0305-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0309-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0310-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0311-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0306-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0307-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
| Jun 7, 2017 | Class II | Z-0308-2019 | Software design | It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as… |
The 5 latest of 14 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 24 years and passes through 3 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, K240844 (Philips Medical Systems Technologies, Ltd., 2024) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K033357.
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. 2017, 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 Philips CT Big Bore is a 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 supports, components and accessories. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology…
Read the full statement (156 words)
The Philips CT Big Bore is a 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 supports, components and accessories. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular 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 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/K171850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K171850: Philips CT Big Bore.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K171850
Report an extraction error
Are you the manufacturer?
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