← Product Code [JAA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA) · K970608 # EVT MARKER BOARD (K970608) _Guidant Cardiac and Vascular Surgery · JAA · Apr 21, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K970608 ## Device Facts - **Applicant:** Guidant Cardiac and Vascular Surgery - **Product Code:** [JAA](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA.md) - **Decision Date:** Apr 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1650 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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. ## Regulatory 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](/device/K930752.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K97D608 APR 21 1997 # IX. SUMMARY OF SAFETY AND EFFECTIVENESS ## SUMMARY OF SAFETY AND EFFECTIVENESS ### MANUFACTURER: EndoVascular Technologies, inc. 1460 O’Brien Drive Menlo Park, CA 94025-1436 Contact: Luanne Termeer ### DEVICE NAME: The EVT® Marker Board is an accessory to an image intensified fluoroscopy x-ray system, 21 CFR 892.1650, Class II. ### SUBSTANTIAL EQUIVALENCE: The EVT® Marker Board is substantially equivalent to the IZI Medical Products Topographic Marker, (K930752, Class II). The EVT® Marker Board is used external to the body. A control box is used to remotely move the position of the markers that are within the marker board. The IZI Medical Products Topographic Markers have adhesive backing which is peeled off and the markers are positioned directly on the body. ### DEVICE DESCRIPTION: The EVT® Marker Board is an all-mechanical aid placed external to the body. It consists of two main components, 1) the polycarbonate plate which houses the radiopaque, movable markers, and 2) the control box which is used to remotely move the position of the markers. ### INTENDED USE: The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures. CONFIDENTIAL EndoVascular Technologies, Inc. Page 20 February 14, 1997 EVT® Marker Board 510(k) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K970608](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K970608) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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