No image

IntraMarX 3D Radiopaque Markers

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.

Details

Device typeRadiological image marker, ingestible: A device intended to be orally introduced for ingestion to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a capsule used to locate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray or nuclear medicine]. This is a single-use device.

FDA categorySystem, Gastrointestinal Motility (Electrical)

Device ID00850015518232

Catalog numberIN-US-5001

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

No contact is listed for this device.

Related products

Product	Model	Company	Device type
Tumark ConicSOMATEX Medical Technologies GmbHRadiological image marker, implantable	351262	SOMATEX Medical Technologies GmbH	Radiological image marker, implantable
Tumark® Vision for Brevera® PetiteSOMATEX Medical Technologies GmbHRadiological image marker, implantable	TUMARK-BREV-P-V-02	SOMATEX Medical Technologies GmbH	Radiological image marker, implantable
N-SPOTBeekley CorporationRadiological image marker, noninvasive, single-use	690S	Beekley Corporation	Radiological image marker, noninvasive, single-use
SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.Radiological image marker, implantable	SMUC10R	Bard Peripheral Vascular, Inc.	Radiological image marker, implantable

Product	Model	Company	Device type