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. This system is based upon the technology and materials of previously marketed Canon CT systems. [...] 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 (FIRST); noise reduction algorithm employing Deep Convolutional Neural Network methods (AiCE)

source quote (p.3)

“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

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 (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: image quality comparison between predicate dual energy scanning and subject Spectral Imaging scanning; reduction of beam hardening artifact; high linear correlation between CT number and iodine concentration

Reader study (MRMC)

sample size not stated

endpoints: diagnostic quality of Spectral Imaging reconstructed images

Bench

sample size not stated

Bench

sample size not stated

endpoints: dose reduction; improvement in low contrast detectability; noise reduction

Reader study (MRMC)

sample size not stated

endpoints: diagnostic quality of AiCE images

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

recalls in product code, 24mo

192

MAUDE reports in code, 12mo

-22%

vs code's own 3-yr baseline

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.

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).