# K970608: Evt Marker Board

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Cardiac and Vascular Surgery
- Decided: Apr 21, 1997 after 62 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930752 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930752: CT/Mri Topographic Marker, I.Z.I. Corp. (1993) Summary page 1.

## Indications for use
The EVT® Marker Board is used to identify anatomical landmarks during fluoroscopic procedures.

Source page: https://510kreport.com/device/K970608
Methodology: https://510kreport.com/methodology