Device type
Interventional Fluoroscopic X-Ray System
Product code OWB · Class II · 21 CFR 892.1650 · Radiology
Interventional fluoroscopy
Recent 510(k)s
Aug 21, 2026
K253726
uAngio AVIVA CX
Shanghai United Imaging Healthcare Co., Ltd.
- OWB
- Class II
Aug 19, 2026
K261413
EXTRON 3;EXTRON 6
DRTECH Corporation
- OWB
- Class II
Recent recalls
Nov 4, 2026
Z-0296-2027
Philips Azurion 7 B12. Model Numbers: 722067, 722225.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0293-2027
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0294-2027
Philips Azurion 5 M12. Model Number: 722227.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0290-2027
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0295-2027
Philips Azurion 5 M20. Model Numbers: 722228, 722281.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0300-2027
Philips Azurion S. Model Number: 722285.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0289-2027
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0297-2027
Philips Azurion 7 B20. Model Numbers: 722068, 722226.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0291-2027
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0298-2027
Philips Azurion 7 M12. Model Numbers: 722078, 722223.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0292-2027
Philips Azurion 3 M12. Model Numbers: 722063, 722221.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0299-2027
Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 3, 2026
Z-0347-2027
Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (MH-500, MH-60),
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- OWB
- Class II
- Open, Classified
Oct 14, 2026
Z-0108-2027
Alphenix INFX-8000C/B5
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Sep 2, 2026
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 co…
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing