Last synced on 17 May 2024 at 11:06 pm

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Page Type
Product Code
Definition
X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.
Physical State
Software device that receives X-ray angiographic image data as an input and provides the user with an image analysis tool that cannot be used alone for clinical decision making and clinical management.
Technical Method
Analyzes X-ray angiographic data using fluid dynamic simulation algorithms to yield simulation-based metrics for certain cardiology applications.
Target Area
X-ray angiographic images of the cardiac vasculature.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1600 Angiographic x-ray system

§ 892.1600 Angiographic x-ray system.

(a) Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Page Type
Product Code
Definition
X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.
Physical State
Software device that receives X-ray angiographic image data as an input and provides the user with an image analysis tool that cannot be used alone for clinical decision making and clinical management.
Technical Method
Analyzes X-ray angiographic data using fluid dynamic simulation algorithms to yield simulation-based metrics for certain cardiology applications.
Target Area
X-ray angiographic images of the cardiac vasculature.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1600
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1600 Angiographic x-ray system

§ 892.1600 Angiographic x-ray system.

(a) Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.