# K022565: Telstar Biplane Digital Imaging System [Tis] Model 030-000915

- Pathway: 510(k) (Special)
- Applicant: Stereotaxis, Inc.
- Decided: Oct 8, 2002 after 67 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: 2 generations back to K900765 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath, Stereotaxis, Inc. (2002) Summary page 1.

## Indications for use
The Telstar™ Biplane Digital Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System.

Source page: https://510kreport.com/device/K022565
Methodology: https://510kreport.com/methodology