EVT MARKER BOARD
Device Facts
| Record ID | K970608 |
|---|---|
| Device Name | EVT MARKER BOARD |
| Applicant | Guidant Cardiac and Vascular Surgery |
| Product Code | JAA · Radiology |
| Decision Date | Apr 21, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
Intended Use
The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.
Device Story
Accessory to image-intensified fluoroscopy x-ray systems; used to identify anatomical landmarks. Device consists of polycarbonate plate housing radiopaque, movable markers and a remote control box. Operated externally to the body; clinician uses control box to adjust marker positions during fluoroscopic procedures. Provides visual reference points on x-ray images to assist in anatomical localization. Benefits include improved precision in landmark identification during interventional procedures.
Clinical Evidence
No clinical data provided; device is an accessory to fluoroscopy systems relying on mechanical design for anatomical landmark identification.
Technological Characteristics
Polycarbonate plate housing radiopaque markers; mechanical control box for remote positioning. External use only. Non-powered/mechanical operation.
Indications for Use
Indicated for use as an external aid to identify anatomical landmarks during fluoroscopic procedures for patients undergoing such imaging.
Regulatory Classification
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
- IZI Medical Products Topographic Marker (K930752)
Related Devices
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- K083274 — WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER · Biocompatibles, Inc. · Jan 8, 2009
- K120613 — OEC 9900 ELITE · Ge Healthcare Surgery GE Oec Medical Systems, Inc. · Apr 6, 2012
- K033619 — NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 · Image-Guided Neurologics, Inc. · Mar 2, 2004
