Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

K192828

Canon Medical Systems Corporation · cleared 2020-02-13 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Aquilion ONE (TSX-306A/3) V10.0 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. This device captures cross sectional volume data sets used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. 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.”
Algorithmiterative reconstruction algorithm; Deep Convolutional Neural Network methods
source quote (p.5)
“FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications. 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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
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 (7)

Bench

sample size not stated

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

Bench

sample size not stated

endpoints: compare the image quality between the predicate dual energy scanning versus the subject Spectral Imaging scanning at varying dose levels

Bench

sample size not stated

endpoints: reduces beam hardening artifact (relative to AIDR3D/FBP); High linear correlation between CT number and iodine concentration

Retrospective clinical

sample size not stated

endpoints: diagnostic quality

Bench

sample size not stated

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

Bench

sample size not stated

endpoints: dose reduction of 69-81%; 18.4% improvement in low contrast detectability; 32% noise reduction; Streak and beam hardening artifacts appeared the same with AiCE as when FBP and AIDR 3D were used and additional artifacts were not introduced; Twice the high contrast spatial resolution of AIDR 3D with reduced noise for AiCE Body Sharp at 10% of the MTF; AiCE noise appearance/texture more similar to high dose filtered backprojection (compared to FIRST); AiCE has improved noise appearance/texture (compared to FIRST); AiCE has more natural noise texture (compared to FIRST); Effective 144 (180 with option) kW max. equivalent generator power with AIDR

Retrospective clinical

sample size not stated

endpoints: 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
11
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) K213504 (decision 2022-06-16) from Canon Medical Systems Corporation for a matching device line ("Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K213504

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K203225 (decision 2021-03-24) from Canon Medical Systems Corporation for a matching device line ("Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K203225

  • 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

  • …and 5 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/K192828