Aquilion Precision (TSX-304A/4) V10.10 with AiCE

K220986

Canon Medical Systems Corporation · cleared 2022-09-12 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Aquilion Precision (TSX-304A/4) V10.10 with AiCE is an ultra-high resolution whole body multi-slice helical CT scanner, consisting of a gantry, couch and a console used for data processing and display. Aquilion Precision incorporates a 160-row, 0.25 mm detector, a 5.7- MHU large-capacity tube, and 0.35 s scanning, enabling wide-range scanning with short scan times to capture cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. In addition, the subject device incorporates the latest reconstruction technology, AiCE (Advanced intelligent Clear-IQ Engine), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Neural Network methods to 1024x1024 HR/SHR images.”
AlgorithmDeep Convolutional Neural Network methods
source quote (p.3)
“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, and cardiac applications.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“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.”

Validation studies (6)

Bench

sample size not stated

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

Reader study (MRMC)

sample size not stated

endpoints: NPS and kurtosis values for FBP, FIRST and AiCE; natural noise texture compared to FIRST images; AiCE noise texture as natural as filtered backprojection and distinct from MBIR images

Bench

sample size not stated

endpoints: high contrast spatial resolution improvement claim of 16.5 lp/cm improvement for Body in HR mode; 10.5 lp/cm improvement for Cardiac in HR mode; 15 lp/cm improvement for Lung in HR mode; more than 10 lp/cm improvement across all AiCE available body regions, all compared to hybrid iterative reconstruction with conventional scanning at the same dose

Bench

sample size not stated

endpoints: High Resolution mode with AiCE is dose neutral relative to AIDR normal resolution mode; High Resolution mode with AiCE has equivalent Low Contrast Detectability relative to normal resolution mode; AiCE has equivalent Low Contrast Detectability with 10lp/cm more high contrast spatial resolution for body

Bench

sample size not stated

endpoints: CT Number Accuracy; Uniformity; Slice Sensitivity Profile (SSP); Modulation Transfer Function (MTF)-Edge; Standard Deviation of Noise (SD); Noise Power Spectra (NPS); equivalent or improved performance for the Aquilion Precision in HR and SHR mode reconstructed with AiCE DLR, relative to the Aquilion ONE GENESIS with AIDR, for Lung Cancer Screening

Retrospective clinical

sample size not stated

endpoints: confirmed that the reconstructed images using the subject device were of diagnostic quality

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
10
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223726 (decision 2023-03-07) from Canon Medical Systems Corporation for a matching device line ("Aquilion Precision (TSX-304A/4) V10.14 with AiCE") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223726

  • 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.

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/K220986