← Back to catalogue

IntraMarX Radiopaque Markers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191087

by Anx Robotica Corp

Identifiers

510(k) Number
K191087 FDA 510(k)
FDA Product Code
FFX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1725 FDA 510(k)
Regulation Number
876.1725 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

IntraMarX Radiopaque Markers are a capsule-based diagnostic tool used for assessing gastrointestinal motility. Each capsule contains 24 tiny radiopaque rings that become visible via abdominal X-ray after the capsule dissolves in the GI tract.

The device is supplied as a single-use capsule and is indicated for use in the diagnosis of GI conditions such as chronic constipation, colonic inertia, hypomotility, and outlet delay. It is classified as an FDA Class II medical device under product code FFX and regulation number 876.1725, with clearance obtained via the traditional 510(k) pathway (K191087).

Frequently asked questions

What is the IntraMarX Radiopaque Markers device used for?

The IntraMarX Radiopaque Markers device is used to assess gastrointestinal motility by tracking the passage of 24 radiopaque rings through the GI tract after capsule dissolution, aiding in the diagnosis of conditions such as chronic constipation, colonic inertia, hypomotility, and outlet delay.

How is the IntraMarX Radiopaque Markers device supplied and is it reusable?

The device is supplied as a single-use capsule and is not intended for reuse; each capsule is designed for one-time administration and dissolution in the gastrointestinal tract to release its radiopaque markers for X-ray imaging.

What are the key specifications of the IntraMarX Radiopaque Markers capsule?

Each capsule contains 24 tiny radiopaque rings that become visible on abdominal X-ray after the capsule dissolves in the GI tract, enabling visualization of marker distribution to evaluate gastrointestinal transit time and motility patterns.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IntraMarX® - AnX Robotics, Products - AnX Robotics, ANX ROBOTICA CORP AGIROMC1-1 (DD) IntraMarX Radiopaque Markers, IntraMarX Radiopaque Markers — FDA Class II Medical Device | MedEquip ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Anx Robotica Corp

Sources (1)

  • FDA 510(k) K191087 24 fields · synced Sep 24, 2026