Alphenix, INFX-8000F/B, V8.0— 510(k) K182415
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K182415 for Alphenix, INFX-8000F/B, V8.0, Substantially Equivalent on 2018-09-28. Applicant: Canon Medical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Canon Medical Systems Corporation
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Otawara-Shi, JP
Recent devices under product code OWB
view allMore clearances from Canon Medical Systems Corporation
view all- K253596 — Aquilion ONE (TSX-308A/TSX-306A) V2.0
- K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- K260078 — Aquilion ServeSP (TSX-307B) V2.0
- K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
- K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K182415
K-number listed on FDA's recall record- Z-3014-2026 — Alphenix Models INFX-8000C INFX-8000F INFX-8000V 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.
- Z-1177-2026 — Alphenix INFX-8000F, interventional fluoroscopic x-ray system
- Z-1155-2024 — The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A revolutionary graphic user interface and a multi-tasking computer enable the system to fully meet the requirement for optimum image quality, safety, ease of use, advanced efficiency and improved workflow. The advanced floormounted system INFX-8000F uses a new flat panel detector to present fluoroscopic and fluorographic images of high quality.
- Z-0492-2022 — Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182415.
Data sourced from openFDA. This site is unofficial and independent of the FDA.