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Canon Medical System, USA, INC.

26 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Alphenix INFX-8000C, interventional fluoroscopic x-ray system recall (Z-1176-2026)Canon Medical System, USA, INC.2026-01-27
Alphenix INFX-8000F, interventional fluoroscopic x-ray system recall (Z-1177-2026)Canon Medical System, USA, INC.2026-01-27
Alphenix INFX-8000H, interventional fluoroscopic x-ray system recall (Z-1178-2026)Canon Medical System, USA, INC.2026-01-27
Alphenix INFX-8000V, interventional fluoroscopic x-ray system recall (Z-1179-2026)Canon Medical System, USA, INC.2026-01-27
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 recall (Z-1017-2026)Canon Medical System, USA, INC.2026-01-13
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 recall (Z-1018-2026)Canon Medical System, USA, INC.2026-01-13
VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. recall (Z-0327-2026)Canon Medical System, USA, INC.2025-10-24
This device is a digital radiography/fluoroscopy system used in a diagnostic and intervent recall (Z-0037-2026)Canon Medical System, USA, INC.2025-10-08
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic im recall (Z-0284-2025)Canon Medical System, USA, INC.2024-11-01
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantag recall (Z-2041-2024)Canon Medical System, USA, INC.2024-06-09
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 recall (Z-1248-2024)Canon Medical System, USA, INC.2024-03-04
MRI system: Vantage Elan, Model: MRT-2020 recall (Z-1249-2024)Canon Medical System, USA, INC.2024-03-04
Vantage Titan, Model: MRT-1504 recall (Z-1250-2024)Canon Medical System, USA, INC.2024-03-04
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and recall (Z-1154-2024)Canon Medical System, USA, INC.2024-02-16
The INFX-8000F is designed to take advantage of the latest technological innovations to re recall (Z-1155-2024)Canon Medical System, USA, INC.2024-02-16
INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE CONSOLE recall (Z-2392-2023)Canon Medical System, USA, INC.2023-08-11
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i7 recall (Z-0198-2023)Canon Medical System, USA, INC.2022-11-08
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-800 recall (Z-1289-2022)Canon Medical System, USA, INC.2022-06-24
Canon Aquilion Lightning, Model TSX-036A recall (Z-1719-2020)Canon Medical System, USA, INC.2020-04-10
Canon Aquilion One, Model TSX-301A recall (Z-1720-2020)Canon Medical System, USA, INC.2020-04-10
Canon Aquilion Premium, Model TSX-301B recall (Z-1721-2020)Canon Medical System, USA, INC.2020-04-10
Canon Aquilion One Vision, Model TSX-301C recall (Z-1722-2020)Canon Medical System, USA, INC.2020-04-10
Canon Aquilion Prime, Model TSX-303A recall (Z-1723-2020)Canon Medical System, USA, INC.2020-04-10
Canon Aquilion Prime SP, Model TSX-303B recall (Z-1724-2020)Canon Medical System, USA, INC.2020-04-10
Canon Aquilion Precision, Model TSX-304A recall (Z-1725-2020)Canon Medical System, USA, INC.2020-04-10
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 recall (Z-1726-2020)Canon Medical System, USA, INC.2020-04-10

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Every clearance here is in the API, with alerts when new ones post.