Company
Canon Medical System, USA, INC.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
54recalls (11 in 12 months)
54recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000V Open, Classified |
OWB | K203551 K233107 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000F Open, Classified |
OWB | K182415 |
| Oct 27, 2026 | Canon Medical System, USA, INC. ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM
REF: INFX-8000C Open, Classified |
OWB | K210900 |
| Oct 7, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000C/B5 Open, Classified |
OWB | K210900 |
| Aug 25, 2026 | Canon Medical System, USA, INC. 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 Open, Classified |
OWB | K182415 K203551 +1 |
| Jan 27, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000V, interventional fluoroscopic x-ray system Open, Classified |
OWB | K233107 |
| Jan 27, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000H, interventional fluoroscopic x-ray system Open, Classified |
OWB | K182546 |
| Jan 27, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000F, interventional fluoroscopic x-ray system Open, Classified |
OWB | K182415 |
| Jan 27, 2026 | Canon Medical System, USA, INC. Alphenix INFX-8000C, interventional fluoroscopic x-ray system Open, Classified |
OWB | K210900 |
| Jan 13, 2026 | Canon Medical System, USA, INC. VANTAGE TITAN 3T
Model MRT-3010/MEXL-3010 Open, Classified |
LNH | K191128 |
| Jan 13, 2026 | Canon Medical System, USA, INC. VANTAGE GALAN 3T
Model MRT-3020/MEXL-3020 Open, Classified |
LNH | K230355 |
| Oct 24, 2025 | Canon Medical System, USA, INC. VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. Open, Classified |
LNH | K243335 |
| Oct 8, 2025 | Canon Medical System, USA, INC. 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 Open, Classified |
OWB | K210900 K233107 |
| Nov 1, 2024 | Canon Medical System, USA, INC. Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Open, Classified |
KPS | K231748 |
| Jun 9, 2024 | Canon Medical System, USA, INC. MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020) Open, Classified |
LNH | K122613 K191128 +3 |
| Mar 4, 2024 | Canon Medical System, USA, INC. Vantage Titan, Model: MRT-1504 Open, Classified |
LNH | K122613 |
| Mar 4, 2024 | Canon Medical System, USA, INC. MRI system: Vantage Elan, Model: MRT-2020 Open, Classified |
LNH | K210164 |
| Mar 4, 2024 | Canon Medical System, USA, INC. MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 Open, Classified |
LNH | K222968 |
| Feb 16, 2024 | Canon Medical System, USA, INC. 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 sys Open, Classified |
OWB | K182415 |
| Feb 16, 2024 | Canon Medical System, USA, INC. 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, be Open, Classified |
OWB | K210900 |
| Aug 11, 2023 | Canon Medical System, USA, INC. INFX-8000C XGCP-930AA TABLE SIDE CONSOLE,
INFX-8000C XGCP-930BA TABLE SIDE CONSOLE Open, Classified |
OWB | K210900 |
| Nov 8, 2022 | Canon Medical System, USA, INC. Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450 Open, Classified |
IYN | K212333 K212960 |
| Jun 24, 2022 | Canon Medical System, USA, INC. System: Alphenix 4D CT in combination with CAS-930A (C arm Support)
Model Number:
INFX-8000C/BF,
INFX-8000C/BH,
INFX-8000C/SW Open, Classified |
OWB | K181804 |
| Jan 31, 2022 | Canon Medical System, USA, INC. INFX-8000V. For radiographic and fluoroscopic studies and intervention. Open, Classified |
OWB | K170909 |
| Dec 20, 2021 | Canon Medical System, USA, INC. Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H. Open, Classified |
OWB | K181670 K181804 +2 |
| May 21, 2021 | Canon Medical System, USA, INC. Canon Vantage Galan 3T, REF: MRT-3020 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic struct Open, Classified |
LNH | K203553 |
| May 21, 2021 | Canon Medical System, USA, INC. Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique image Open, Classified |
LNH | K172878 |
| May 21, 2021 | Canon Medical System, USA, INC. Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique im Open, Classified |
LNH | K170412 |
| May 21, 2021 | Canon Medical System, USA, INC. Toshiba Vantage Tiitan 1.5T with Standard gradient, Premium Open-Bore MRI System, REF: MRT-1504 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, Open, Classified |
LNH | K122613 |
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000F Open, Classified |
MQB | K081624 |
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000C Open, Classified |
OWB | K152697 |
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000V Open, Classified |
OWB | K170909 |
| Dec 8, 2020 | Canon Medical System, USA, INC. Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F
Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ang Open, Classified |
MQB | K081624 |
| Dec 8, 2020 | Canon Medical System, USA, INC. Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C
Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ang Open, Classified |
OWB | K152697 |
| Dec 8, 2020 | Canon Medical System, USA, INC. Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and an Open, Classified |
OWB | K170909 |
| Nov 11, 2020 | Canon Medical System, USA, INC. Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Terminated |
KPS | K203314 |
| Nov 9, 2020 | Canon Medical System, USA, INC. Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. Terminated |
JAK | K192832 |
| Oct 8, 2020 | Canon Medical System, USA, INC. CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiogr Terminated |
OWB | K152697 K181804 |
| Jul 8, 2020 | Canon Medical System, USA, INC. System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147 Open, Classified |
OWB | K181834 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 Open, Classified |
JAK | K170177 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Precision, Model TSX-304A Open, Classified |
JAK | K173468 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Prime SP, Model TSX-303B Open, Classified |
JAK | K172188 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Prime, Model TSX-303A Open, Classified |
JAK | K120710 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One Vision, Model TSX-301C Open, Classified |
JAK | K151673 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Premium, Model TSX-301B Open, Classified |
JAK | K120546 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion One, Model TSX-301A Open, Classified |
JAK | K093891 |
| Apr 10, 2020 | Canon Medical System, USA, INC. Canon Aquilion Lightning, Model TSX-036A Open, Classified |
JAK | K170019 |
| Mar 3, 2020 | Canon Medical System, USA, INC. Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration Open, Classified |
MQB | K081624 |
| Mar 3, 2020 | Canon Medical System, USA, INC. Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration Open, Classified |
OWB | K152697 |
| Mar 3, 2020 | Canon Medical System, USA, INC. Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration Open, Classified |
OWB | K170909 |
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