Aquilion ServeSP (TSX-307B) V2.0

K260078

Canon Medical Systems Corporation · cleared 2026-03-13 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications. PIQE is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Neural Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac, abdomen, pelvis, and lung applications, in comparison to FBP and hybrid iterative reconstruction. CLEAR Motion is a Deep Learning Reconstruction (DLR) method designed to reduce motion artifacts. A Deep Convolutional Neural Network (DCNN) is used to estimate the patient's motion.”
AlgorithmDeep Convolutional Neural Network (DCNN) based algorithms for noise reduction, spatial resolution enhancement, and motion artifact reduction.
source quote (p.4)
“AiCE (Advanced Intelligent Clear-IQ Engine) is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, cardiac, extremities, head and inner ear applications. PIQE is a Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Neural Network (DCNN), it is possible to achieve both spatial resolution improvement and noise reduction for cardiac, abdomen, pelvis, and lung applications, in comparison to FBP and hybrid iterative reconstruction. CLEAR Motion is a Deep Learning Reconstruction (DLR) method designed to reduce motion artifacts. A Deep Convolutional Neural Network (DCNN) is used to estimate the patient's motion.”
Adaptive (vs locked)Yes
source quote (p.7)
“The Al model adapts to variations in noise texture and anatomical motion patterns, with the final output demonstrating improved clarity of lung and heart structures, with suppression of motion blur and enhanced diagnostic quality.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Cybersecurity documentation, per the FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, issued on June 27, 2025, was included in this submission.”

Validation studies (5)

Bench

sample size not stated

endpoints: reduced motion artifacts without introducing distortion or loss of anatomical structures

Bench

sample size not stated

endpoints: minimal CT number variation; no visual artifacts; enhancement of image quality by compensating for motion during reconstruction

Bench

sample size not stated

endpoints: reduce motion artifacts in lung CT imaging across various anatomical structures including pulmonary vessels, airways, and the diaphragm; improving spatial fidelity and diagnostic clarity

Retrospective clinical

n=5 cases

endpoints: improve image quality by reducing motion artifacts without introducing distortion or loss of anatomical structures; consistent visual improvement in motion artifacts; performance remained stable across different display field-of-view (dFOV) settings; improving diagnostic image quality

Standalone

sample size not stated

endpoints: contrast-to-noise ratio (CNR); CT number accuracy; uniformity; modulation transfer function (MTF); noise power spectra (NPS); low contrast detectability (LCD); noise reduction; spatial resolution; signal-to-noise ratios

Reported performance (2 observations)

accuracyas written: “CT number accuracy”stated without value
source quote (p.9)
“PIQE was benchmarked against Filtered Backprojection (FBP) and AIDR Enhanced (AIDR3D) across multiple clinical and phantom-based metrics, including contrast-to-noise ratio (CNR), CT number accuracy, uniformity, modulation transfer function (MTF), noise power spectra (NPS), and low contrast detectability (LCD).”
accuracyas written: “CT value accuracy”stated without value
source quote (p.8)
“Quantitative analysis showed consistent CT value accuracy with and without CLEAR Motion, and visual assessments”

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

75
recalls in product code, 24mo
192
MAUDE reports in code, 12mo
-22%
vs code's own 3-yr baseline
9
drift signals on this device
  • 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 matches this device's applicant.

    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.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K260078