Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
K251602Canon Medical Systems Corporation · cleared 2025-10-10 · product code OWB · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with αEvolve Imaging includes αEvolve Imaging, an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).”
source quote (p.4)
“aEvolve Imaging is an imaging chain intended for adults, with Artificial Intelligence Denoising (AID) designed to reduce noise in real-time fluoroscopic images and signal enhancement algorithm, Multi Frequency Processing (MFP).”
source quote (p.10)
“Cybersecurity documentation followed FDA cybersecurity premarket guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023.”
Validation studies (2)
Bench
sample size not stated
endpoints: noise reduction; change in image level; preservation of structural similarity index measurement (SSIM); Signal-to-Variance Ratio (SVR); Signal-to-Noise Ratio (SNR); Modulation Transfer Function (MTF); Normalizes Noise Power Spectrum (NNPS); Image Lag Measurement; Contrast-to-Noise Ratio (CNR) of low-contrast objects; Contrast-to-Noise Ratio (CNR) of high-contrast objects; Robustness to Detector Defects
standards: IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2014 + A1:2020, IEC 60601-1-3:2008+A1:2013+A2:2021, IEC 60601-1-6:2010+A1:2013+A2:2020, IEC 60601-2-28:2017, IEC 60601-2-43:2010+A1:2017+A2:2019, IEC 62304:2006+A1:2015, IEC 62366-1:2015 + A1:2020, IEC 81001-5-1:2021, ISO 17664-2:2021, IEC TR 60601-4-2:2016
Reader study (MRMC)
sample size not stated · 3 site(s)
endpoints: superior performance of the AID imaging chain compared to SNRF (Wilcoxon signed rank test); image sequences denoised by AID chosen significantly more than 50% of the time (Binomial test); mean score of the AID imaging chain images significantly higher than that of the SNRF imaging chain with regard to sharpness, contrast, confidence, noise, and the absence of image artifacts
standards: IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2014 + A1:2020, IEC 60601-1-3:2008+A1:2013+A2:2021, IEC 60601-1-6:2010+A1:2013+A2:2020, IEC 60601-2-28:2017, IEC 60601-2-43:2010+A1:2017+A2:2019, IEC 62304:2006+A1:2015, IEC 62366-1:2015 + A1:2020, IEC 81001-5-1:2021, ISO 17664-2:2021, IEC TR 60601-4-2:2016
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253584 (decision 2026-03-10) from Canon Medical Systems Corporation for a matching device line ("Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253584
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2026-05-20): "Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99079
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Medtronic Navigation, Inc.-Boxborough, initiated 2026-05-19): "Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99041
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2025-12-29): "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98244
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains i" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98096
- recall_reason_pattern
Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98108
- …and 2 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).