Identity
- Trade Name
- IntraMarX 3D FDA UDI
- Generic Name
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
- Device Name
- The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D 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 x-ray 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. FDA UDI
- Model / Reference
- AGIROMIC2-1-TC/1 FDA UDI
- Description
- The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D 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 x-ray 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. FDA UDI
Identifiers
- Catalog Number
- AGIROMIC2-1-TC/1 FDA UDI
- Primary DI / UDI-DI
- 00850015518171 FDA UDI
- 510(k) Number
- K201106 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastrointestinal telemetric monitoring system capsule, ingestible FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastrointestinal telemetric monitoring system capsule, ingestible
IntraMarX 3D by Anx Robotica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastrointestinal telemetric monitoring system capsule, ingestible.
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- Sitzmarks Radiopaque Markers — KONSYL PHARMACEUTICALS, INC. · Class II
- PillSense Capsule — Enterasense , Ltd. · Class II
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- Heidelberg pH Capsule System — Heidelberg Medical Inc · Class I
- alpHaONE — Chongqing Jinshan Science & Technology (Group) Co., Ltd · Class I
Cleared under the same submission
K201106 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Anx Robotica Corp.
Sources (1)
- FDA UDI a1d1cbe2-823e-4b39-92be-5752c7c13a39 35 fields · synced Jun 8, 2026