XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

K232526

Canon Medical Systems Corporation · cleared 2023-09-12 · product code JAA · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“Dynamic Device Stabilizer (DDS) software with deep learning is changed to improve the detection rate of the stent marker.”
Algorithmdeep learning
source quote (p.6)
“Dynamic Device Stabilizer (DDS) software with deep learning is changed to improve the detection rate of the stent marker.”
Adaptive (vs locked)No
source quote (p.6)
“Testing was conducted to verify the fixed display performance was improved in V9.5 algorithm compared to V9.3 algorithm for Dynamic Device Stabilizer (DDS) in XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: fixed display performance was improved

standards: IEC60601-1-2:2014 + A1:2020, IEC62304:2006 + A1:2015, IEC 62366-1:2015 + A1:2020, IEC 81001-5-1:2021, IEC 62368-1:2014, ISO 14971:2007

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

9
recalls in product code, 24mo
31
MAUDE reports in code, 12mo
-5%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code JAA (SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku, initiated 2024-09-06): "X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lea" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95450

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/K232526