XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K232526Canon Medical Systems Corporation · cleared 2023-09-12 · product code JAA · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 is used for images input from Diagnostic Imaging System and Workstation, image processing and display. The processed images can be outputted to Diagnostic Imaging System and Workstation. Dynamic Device Stabilizer (DDS) software with deep learning is changed to improve the detection rate of the stent marker.”
source quote (p.6)
“Dynamic Device Stabilizer (DDS) software with deep learning is changed to improve the detection rate of the stent marker.”
source quote (p.6)
“LIST OF APPLICABLE STANDARDS IEC 81001-5-1:2021”
Validation studies (1)
Bench
sample size not stated
endpoints: established specifications for the device have been met; fixed display performance was improved in V9.5 algorithm compared to V9.3 algorithm for Dynamic Device Stabilizer (DDS)
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
- 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). 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).