Interventional Fluoroscopic X-Ray System
Regulation 892.1650
19510(k)s in 12 months (325 all time)
109recalls in 12 months (637 all time)
606recalls that name a 510(k)
Top companies in OWB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion S. Model Number: 722285. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 M12. Model Numbers: 722078, 722223. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B20. Model Numbers: 722068, 722226. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7 B12. Model Numbers: 722067, 722225. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M20. Model Numbers: 722228, 722281. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5 M12. Model Number: 722227. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M15. Model Number: 722064, 722222, 722280. Open, Classified |
OWB | K172822 K181830 +1 |
| Oct 27, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3 M12. Model Numbers: 722063, 722221. Open, Classified |
OWB | K172822 K181830 +1 |
| 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 |
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system Open, Classified |
OWB | K200917 |
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models ar Open, Classified |
OWB | K163715 K172822 +1 |
| Aug 10, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058.
Interventional fluoroscopic x-ray system. Open, Classified |
OWB | K133292 K141979 +2 |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400.
Interventional Fluoroscopic X-Ray System. Open, Classified |
OWB | K102005 K130638 +4 |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion under the following System Descriptions and corresponding model numbers:
1. Azurion 3 M12; Model Numbers: 722063, 722221.
2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280.
Open, Classified |
OWB | K172822 K181830 +1 |
| Aug 5, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura under the following System Descriptions and corresponding model numbers:
1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026.
2. Allura Xper FD10 OR Table; Model Number: 7220 Open, Classified |
OWB | K102005 K130638 +3 |
| Aug 3, 2026 | Oxos Medical Inc Brand Name: OXOS Medical, Inc
Product Name: MC2 Portable X-Ray System
Model/Catalog Number: MC2, MC2.1
Software Version: 5.7.0
Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 Open, Classified |
OWB | K252068 |
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono ceiling. Model Number: 11328100. Open, Classified |
OWB | K221516 |
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono floor. Model Number: 11327700. Open, Classified |
OWB | K241572 |
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono ceiling. Model Number: 11328100. Open, Classified |
OWB | K241572 |
| Jul 1, 2026 | Siemens Medical Solutions USA, Inc ARTIS icono biplane. Model Number: 11327600. Open, Classified |
OWB | K241572 |
| Jun 16, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD Open, Classified |
OWB | K102005 K130638 +4 |
| Jun 15, 2026 | Medtronic Navigation, Inc.-Boxborough Medtronic O-arm O2 Imaging System. Model Number: BI70002000. Open, Classified |
OWB | K240465 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia Moveo angiographic X-ray system Open, Classified |
OWB | K251199 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 7 Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 5 Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 3 Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| Jun 4, 2026 | Siemens Medical Solutions USA, Inc ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system Open, Classified |
OWB | K241572 |
| Jun 4, 2026 | Siemens Medical Solutions USA, Inc ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system Open, Classified |
OWB | K241572 |
| Jun 2, 2026 | Shimadzu Medical Systems Digital Angiography System Trinias:UD150G-40 / D150GC-40;
Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40;
Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40;
Digital Rad Open, Classified |
OWB | K062360 K123508 +4 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| Jun 1, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key Open, Classified |
OWB | K172822 K181830 +1 |
| May 28, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper Open, Classified |
OWB | K102005 K130638 +4 |
| May 28, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Open, Classified |
OWB | K102005 K130638 +4 |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers.
1. Azurion 3 M12; Model Numbers: 722063, 722229 Open, Classified |
OWB | K172822 K181830 +1 |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-Nicol (722030), Integris Allura 15 & 12 (monoplane) (722043), INTEGRIS Allura 15-12 (biplane) (722044 Open, Classified |
OWB | None listed |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Open, Classified |
OWB | None listed |
| May 21, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, Open, Classified |
OWB | None listed |
| May 12, 2026 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 7222 Open, Classified |
OWB | K172822 K181830 +1 |
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