Radiology · 510(k) · 2026
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
Canon Medical Systems Corporation. Cleared by FDA on 10 March 2026 under submission K253584, product code OWB (interventional fluoroscopic x-ray system). What FDA's record says, in FDA's words.
Device record · K253584
- Device. Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)DEVICE
- Company. Canon Medical Systems Corporation (JP)COMPANY
- Decision. 10 March 2026, 510(k), substantially equivalent (traditional review); received 17 November 2025DECISION
- Panel. RadiologyPANEL
- Product code. OWB, Interventional Fluoroscopic X-Ray SystemCODE
- Regulation. 21 CFR 892.1650, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K258534Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? lAlphenix, INFX-800OV/B, INFX-800OV/S, V9.6 with aEvolve Imaging (FOV Extension) Please provide your Indications for Use below. This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities. 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). I Please select the types of uses (select one or both, as ZPrescription Use (21 CFR 801 Subpart D) S]Over-The-Counter Use (21 CFR 801 Subpart C)applicable). –– 510(k) SUMMARY This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92
The product code's definition, from FDA's classification record. Interventional fluoroscopy
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsa diagnostic claim
- Mentionsprescription use
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 50,680 reports filed against devices carrying product code OWB. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002661
It was reported to Philips that the system was unable to start up properly.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002659
It was reported to Philips that the system was experiencing booting issues.The system was not in clinical use during the event. No harm was reported to the user or the patient during the event.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002662
It was reported to Philips that the system was unable to perform exposure.The system was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD20 · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002664
It was reported to Philips that the system's propellor geometry movement was not available.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · Allura Xper FD · Philips Medical Systems Nederland B.V. · report 3042175844-2026-002665
It was reported to Philips that the system could not emit X-ray.The device was in clinical use at the time of the event. No harm to the patient or user was reported.Philips has started an investigation of this complaint.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OWB, in Radiology, from Canon Medical Systems Corporation, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.