Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2— 510(k) K210900
Substantially EquivalentCanon Medical Systems Corporation
FDA 510(k) clearance K210900 for Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2, Substantially Equivalent on 2021-04-12. 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
- Special
- 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 K210900
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-1176-2026 — Alphenix INFX-8000C, interventional fluoroscopic x-ray system
- Z-0037-2026 — 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-1154-2024 — The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient radiographic table.
- Z-2392-2023 — INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210900.
Data sourced from openFDA. This site is unofficial and independent of the FDA.