ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
Siemens Medical Solutions USA, IncThe ARTIS icono (VE40A) family and ARTIS pheno (VE40A) are advanced angiography systems that enable detailed imaging for diagnostic and interventional procedures. They support single-plane and biplane imaging with a motorized C-arm and flat panel detector, allowing clinicians to perform cardiac, neuro, general angiography, and image-guided surgeries. The systems provide 2D and 3D imaging capabilities, including 3D reconstruction software (DynaCT), which helps clinicians visualize both hard and soft tissues for diagnosis, surgical planning, and treatment follow-up.
Intended Use
ARTIS is a family of dedicated angiography systems developed for single-plane and biplane diagnostic imaging and interventional procedures including pediatric and obese patients. Procedures include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography, whole body radiographic/fluoroscopic procedures, image guided surgery by X-ray, image fusion, and navigation systems. Includes software DynaCT for 3D image reconstruction from 2D angiographic images for diagnosis, surgical planning, interventional procedures and treatment follow-up.
Technology
The ARTIS Family (VE40A) is comprised of components such as a patient table, multi-axis motorized C-arm with flat panel detector, X-ray tube, collimator, high voltage generator, and image post-processing software. The system supports multiple configurations (floor, biplane, ceiling, pheno) and allows 2D and 3D imaging. The software update from VE30A to VE40A adds optional displays and improved features such as ceiling stand lateral movement. The system integrates with syngo application software and supports acquisition of spatial imaging data.
Performance
Nonclinical performance testing included software functional, verification, and system validation testing with passing results. The system complies with multiple IEC and ISO standards for electrical safety, electromagnetic compatibility, biocompatibility, usability, and cybersecurity. Testing demonstrated the device is as safe and effective as predicate devices, with all acceptance criteria met. Risk management was conducted with hazard analysis, and software validation confirmed substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2024
4 months - 2
FDA Approval
10/22/2024
Other devices from Siemens Medical Solutions USA, Inc
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