TAVI(Trans catheter Aortic Valve Implantation) precision treatment planning application has received US FDA 510(k) clearance.This application is developed by Roayal Philips.
This TAVI planning applications using 3D imaging will provide interventionalists with high precision positioning to treat Aortic stenosis ailments .With advanced computed tomography imaging ,it provides planes and panel measuremnts for precisely placing TAVI device to manage risk of under or over sizing of the device.
This TAVI planning Application is available as a part of Royal Philips IntelliSpace portal6 which is the company's advanced visualisation and analysis solution that allow access and analyze patient imaging and data virtually anywhere at any time.
510(k) is a section of Federal Food ,drug and cosmetics act which requires those device manufacturers who must register to notify FDA, at least Ninty days(90 days) in advance of their intent to market a Medical Device.This is also known as PREMARKET NOTIFICATION.
NOTE:Any device that reaches market via 510(K) process is not considered to be approved by the FDA . However, it can be marketed and sold in US.
This TAVI planning applications using 3D imaging will provide interventionalists with high precision positioning to treat Aortic stenosis ailments .With advanced computed tomography imaging ,it provides planes and panel measuremnts for precisely placing TAVI device to manage risk of under or over sizing of the device.
This TAVI planning Application is available as a part of Royal Philips IntelliSpace portal6 which is the company's advanced visualisation and analysis solution that allow access and analyze patient imaging and data virtually anywhere at any time.
510(k) is a section of Federal Food ,drug and cosmetics act which requires those device manufacturers who must register to notify FDA, at least Ninty days(90 days) in advance of their intent to market a Medical Device.This is also known as PREMARKET NOTIFICATION.
NOTE:Any device that reaches market via 510(K) process is not considered to be approved by the FDA . However, it can be marketed and sold in US.