FDA.reportPublic FDA data

IntraMarX 3D

Primary DI
00850015518164
Brand
IntraMarX 3D
Company
ANX ROBOTICA CORP
Model
AGIROMC2-1-O/1
Catalog number
AGIROMC2-1-O/1
Device 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.
Published
2020-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFXSystem, Gastrointestinal Motility (Electrical)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201106000IntraMarX 3D Radiopaque MarkerAnx Robotica Corp2020-05-21FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015518164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015518164008500155181648500155181640850015518164

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring system capsule, ingestedA battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024972857
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810164590114NaviCam Data RecorderSB-US-2003SB-US-20032026-02-16
00810164590145NaviCam LocatorSB-US-2006SB-US-20062026-02-16
00810164590169NaviCam ESView SoftwareESView 2.XSB-US-20062026-02-16
00810164590275NaviCam ProScan AI SoftwareSB-US-2025SB-US-2-252026-02-16
00810164590794NaviCam ESView 3.XESView 3.XSB-US-20262026-02-16
00810164590008NaviCam SB CapsuleCP-US-7001CP-US-70012026-02-09
00810164590039NaviCam SB Capsule/TetherES-US-3001ES-US-30012026-02-09
00810164590633MotiliCap GI Monitoring System Data RecorderMO-US-8001MO-US-80012026-02-09
00810164590640MotiliCap GI Monitoring System Software (MotiliScan)MO-US-8005MO-US-80052026-02-09
00810164590657MotiliCap GI Monitoring System CapsuleCP-US-7010CP-US-70102026-02-09
00810164590718NaviCam XS CapsuleCP-US-7009CP-US-70092026-02-09
00810164590732NaviCam XS Capsule/TetherES-US-3009ES-US-30092026-02-09
00810164590817MotiliCap GI Monitoring System Mobile Phone/AppMO-US-8010MO-US-80102026-02-09
00850015518287NaviCam TetherCEE-1ES-US-30022023-01-05
00850015518294NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach SystemController/ NaviEC-2000MC-US-10022023-01-05
00850015518072NaviCam Stomach SystemLocator AKS-1SB-US-20062020-12-08
00850015518188NaviCam Capsule Endoscope SystemRecorder/AKR-1MC-US-10062020-12-08
00850015518195NaviCam Capsule Endoscope SystemStomach Capsule/AKEM-11SWCP-US-70062020-12-08
00850015518201NaviCam Capsule Endoscope SystemController/NaviEC-1000MC-US-10012020-12-08
00850015518003IntraMarX Radiopaque MarkersAGIROMC1-1(R)AGIROMC1-1(R)2020-01-27

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