CT 5300
K232491Philips Healthcare (Suzhou) Co., Ltd. · cleared 2024-05-03 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The proposed device is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.”
source quote (p.11)
“design of the AI algorithm, the body joints detection algorithm including CNN architecture, model parameters, inference pipeline, pre- and post-processing is same as what is used in the predicate Incisive CT.”
source quote (p.9)
“Guidance for Industry and FDA Staff – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued September 27, 2023, document number GUI00001825)”
Validation studies (1)
Retrospective clinical
n=31 patients
endpoints: equal or greater diagnostic quality
standards: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) [Incl. AMD2:2021] Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD) [Incl. AMD2:2021]., IEC 60601-1-2:2020 (Consolidated Text) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests, IEC 60601-1-3:2021(Consolidated Text) Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment, IEC 60601-1-6:2020(Consolidated Text) Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability, IEC 60601-2-44:2016 Medical electrical equipment - Part 2-44: Particular requirements for the safety and essential performance of X-ray equipment for computed tomography, IEC 62304:2015 (Consolidated Text) Medical device software -- Software life cycle processes, IEC 62366-1:2020 Medical devices -- Part 1: Application of usability engineering to medical devices, ISO14971:2019 Medical devices – Application of risk management to medical devices, ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, NEMA XR 25-2019 Computed Tomography Dose Check, NEMA XR 26:2020 Access Controls for Computed Tomography: Identification, Interlocks, and Logs, NEMA XR 28-2018 Supplemental Requirements for User Information and System Function Related to Dose in CT, NEMA XR 29-2013 Standard Attributes on CT Equipment Related to Dose Optimization and Management
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98738
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
- …and 3 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).