Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

K213504

Canon Medical Systems Corporation · cleared 2022-06-16 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.10)
“Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System is a whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. AiCE 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, brain, inner ear and extremities applications.”
AlgorithmDeep Convolutional Neural Network methods, Deep Learning Reconstruction method designed to enhance spatial resolution. By incorporating noise reduction into the Deep Convolutional Neural Network (DCNN)
source quote (p.10)
“AiCE 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, brain, inner ear and extremities 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 applications.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.14)
“Cybersecurity documentation, per the FDA cybersecurity premarket guidance document “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” issued on October 2, 2014, is also included as part of this submission. Based upon this information it should be noted that CyberSecurity requirements do not apply to this device.”

Validation studies (6)

Bench

sample size not stated

endpoints: Contrast-to-Noise Ratios (CNR); CT Number Accuracy; Uniformity; Slice Sensitivity Profile (SSP); Modulation Transfer Function (MTF)-Wire; Modulation Transfer Function (MTF)-Edge; Standard Deviation of Noise (SD); Noise Power Spectra (NPS); Low Contrast Detectability (LCD); Pediatric imaging

Bench

sample size not stated

endpoints: high contrast spatial resolution

Bench

sample size not stated

endpoints: Reduced noise; Improved Off-Center Resolution; Improved signal/object visualization for the most common cardiac tasks; Reduced noise without loss of noise texture; Improved spatial resolution and simultaneously reduced noise; Improved CT number accuracy for fine structures; Improved CNR in all planes

Bench

sample size not stated

endpoints: Contrast-to-Noise Ratios (CNR); CT Number Accuracy; Uniformity; Slice Sensitivity Profile (SSP); Modulation Transfer Function (MTF)-Edge; Standard Deviation of Noise (SD); Noise Power Spectra (NPS); Low Contrast Detectability (LCD)

Bench

sample size not stated

endpoints: dose reduction

Bench

sample size not stated

endpoints: ability to produce substantially equivalent 3D and 2D scanongrams

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

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/K213504