# K201106: IntraMarX 3D Radiopaque Marker

- Pathway: 510(k) (Special)
- Applicant: Anx Robotica Corp
- Decided: May 21, 2020 after 27 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- 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 K181750 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191087: IntraMarX Radiopaque Markers, Anx Robotica Corp (2019) Summary page 4.

## Indications for use
IntraMarX 3D Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult, IntraMarX 3D Radiopaque Markers is dispensed only by physicians to patients for oral intake.

Source page: https://510kreport.com/device/K201106
Methodology: https://510kreport.com/methodology