Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
K192832Canon Medical Systems Corporation · cleared 2020-02-21 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The Aquilion Prime SP (TSX-303B/8) V10.2 with AiCE-i is a 40-row CT System that is intended to acquire and display cross-sectional volumes of the whole body, including the head. In addition, the subject device incorporates the latest reconstruction technology, AiCE-i (Advanced intelligent Clear-IQ Engine - integrated), intended to reduce image noise and improve image quality by utilizing Deep Convolutional Neural Network methods.”
source quote (p.3)
“AiCE (Advanced Intelligent Clear-IQ Engine) 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, extremities, head and inner ear applications.”
source quote (p.5)
“By learning to differentiate structure from noise, the algorithm produces fast, high quality CT reconstruction.”
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 (5)
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 phantom/protocol
Bench
sample size not stated
endpoints: dose reduction; improved low contrast detectability; noise reduction
Bench
sample size not stated
endpoints: low-contrast detectability of 1.5 mm at 0.3%
Reader study (MRMC)
sample size not stated
endpoints: Noise appearance/texture more similar to high dose filtered backprojection compared to MBIR; Noise appearance/texture more similar to filtered backprojection compared to MBIR; Improved noise appearance/texture compared to MBIR; More natural noise texture compared to MBIR
Reader study (MRMC)
sample size not stated
endpoints: diagnostic quality of AiCE reconstructed 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
- 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.
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).