Philips Incisive CT
K212441Philips Healthcare (Suzhou) Co., Ltd. · cleared 2022-04-27 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.14)
“Precise image reconstruction is a recon mode where the system uses a trained deep learning neural network to generate noise reduction images and improve low contrast detectability with reduced dose compared with standard FBP recon mode.”
source quote (p.14)
“Precise image reconstruction is a recon mode where the system uses a trained deep learning neural network to generate noise reduction images and improve low contrast detectability with reduced dose compared with standard FBP recon mode.”
source quote (p.8)
“Guidance for Industry and FDA Staff — Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014)”
Validation studies (1)
Bench
sample size not stated
standards: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)., IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests, IEC 60601-1-3:2013 Medical electrical equipment -- Part 1-3: General requirements for basic safety - Collateral standard: Radiation protection in diagnostic X-ray equipment, IEC 60601-1-6:2013 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 Medical device software -- Software life cycle processes, IEC 62366-1:2015, Medical devices -- Part 1: Application of usability engineering to medical devices, ISO14971 Medical devices – Application of risk management to medical devices (Ed. 3.0, 2019), NEMA XR 25-2010 Computed Tomography Dose Check, NEMA XR 28-2013 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K223311 (decision 2022-12-22) from Philips Healthcare (Suzhou) Co., Ltd for a matching device line ("Philips CT 3500") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K223311
- 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
- …and 4 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).