# K171850: Philips CT Big Bore

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Nov 9, 2017 after 141 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 11 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033357: Acqsim-Multislice-CT, Model 453567042271, Philips Medical Systems (Cleveland), Inc. (2004) Summary page 5.

## Most influential descendants
- K240844: Spectral CT 7500 RT (2024), 3 descendants of its own
- K181797: Philips CT Big Bore Sliding Gantry Configuration (2018), 1 descendant of its own
- K253649: Spectral CT Verida Family (2026), 0 descendants of its own
- K252992: CT Rembra RT; CT Areta RT; CT Rembra (2026), 0 descendants of its own
- K244008: Spectral CT (2025), 0 descendants of its own

## Recalls of this device
- Aug 13, 2025 · Class II · Z-2597-2025: 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: 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: 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)
- Oct 9, 2023 · Class II · Z-0292-2024: 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)
- Oct 9, 2023 · Class II · Z-0294-2024: 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)
- Jun 7, 2017 · Class II · Z-0303-2019: 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 
- Jun 7, 2017 · Class II · Z-0304-2019: 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 
- Jun 7, 2017 · Class II · Z-0305-2019: 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 
- Jun 7, 2017 · Class II · Z-0309-2019: 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 
- Jun 7, 2017 · Class II · Z-0310-2019: 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 
- Jun 7, 2017 · Class II · Z-0311-2019: 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 
- Jun 7, 2017 · Class II · Z-0306-2019: 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 
- Jun 7, 2017 · Class II · Z-0307-2019: 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 
- Jun 7, 2017 · Class II · Z-0308-2019: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K171850
Methodology: https://510kreport.com/methodology