IntraMarX Radiopaque Markers
IntraMarX Radiopaque Markers help a physician evaluate movement through the colon in adults with severe constipation and otherwise negative gastrointestinal evaluations. The physician…
IntraMarX Radiopaque Markers help a physician evaluate movement through the colon in adults with severe constipation and otherwise negative gastrointestinal evaluations. The physician dispenses a capsule for the patient to swallow. Each capsule contains 24 small markers that remain visible on an abdominal X-ray.
As the capsule travels through the digestive tract, its shell dissolves and releases the markers. An abdominal X-ray taken five days after ingestion shows where the markers are and how many remain. The physician uses this distribution to assess colonic motility.
Listed Item
The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
Capsule and Markers
The capsule shell is made from hydroxypropyl methylcellulose. The markers contain polyvinyl chloride, a plasticizer and barium sulfate, and are available in ring, double-D and tri-chamber shapes. Each capsule is for single use.
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Medical Technologies (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
Record
| Listed by | ANX Robotica Corp., United States |
|---|---|
| FDA product code | FFX |
| Device type | System, Gastrointestinal Motility (Electrical) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K191087 |
| Record published | 2020-01-27 |
| Record revised | 2022-11-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 12, cartoon of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AGIROMC1-1(R) | 10 | In distribution | |
| AGIROMC1-1(TC) | 10 | In distribution | |
| AGIROMC1-1(DD) | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mui Scientific | H&A Mui Enterprises, Inc. | 771 |
| UniTip High Resolution Catheter | Unisensor AG | 183 |
| UniTip Catheter | Unisensor AG | 100 |
| ManoScan | Given Imaging Ltd. | 60 |
| Diversatek Healthcare | Diversatek Healthcare Inc | 27 |
| inSIGHT Ultima | Diversatek Healthcare Inc | 19 |
| Endoflip | Covidien LP | 17 |
| Sitzmarks Radiopaque Markers | Konsyl Pharmaceuticals, Inc. | 14 |
| Zvu® | Diversatek Healthcare Inc | 11 |
| Distender II Barostat | G & J Electronics, Inc. | 9 |
| PriZm | Diversatek Healthcare Inc | 8 |
| ManoView | Given Imaging Ltd. | 6 |
Showing 12 of 107. All products under System, Gastrointestinal Motility (Electrical)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201106 | 2020-05-21 |
| K191087 | 2019-12-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.