Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
K182901Canon Medical Systems Corporation · cleared 2019-07-05 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Aquilion Precision (TSX-304A/1 and /2) V8.8 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. 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.”
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 and pelvis applications.”
source quote (p.7)
“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 (1)
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 water phantom; low contrast detectability; noise reduction; dose neutrality; high contrast spatial resolution improvement
standards: IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, NEMA PS 3.1-3.18, NEMA XR-25, NEMA XR-26, NEMA XR-29, 21 CFR §1010, 21 CFR §1020, ISO 13485
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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K220986 (decision 2022-09-12) from Canon Medical Systems Corporation for a matching device line ("Aquilion Precision (TSX-304A/4) V10.10 with AiCE") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220986
- 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).