Imaging device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.
AltaTrack - AltaTrack equipment
Device Description
An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DQK
Device Name: Computer, Diagnostic, Programmable
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1425
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00884838099340
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A