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NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System

FDA UDI

Class II (US FDA UDI)

by Anx Robotica Corp.

Identity

Trade Name
NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System FDA UDI
Generic Name
Video capsule endoscopy system capsule magnetic manipulation unit FDA UDI
Device Name
Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator FDA UDI
Model / Reference
Controller/ NaviEC-2000 FDA UDI
Description
Controller. The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator FDA UDI

Identifiers

Catalog Number
MC-US-1002 FDA UDI
Primary DI / UDI-DI
00850015518294 FDA UDI
510(k) Number
K203192 FDA UDI
FDA Product Code
QKZ FDA UDI
GMDN Term
Video capsule endoscopy system capsule magnetic manipulation unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Video capsule endoscopy system capsule magnetic manipulation unit

NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System by Anx Robotica Corp. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Video capsule endoscopy system capsule magnetic manipulation unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anx Robotica Corp.

Sources (1)

  • FDA UDI ae94ceab-09c4-41f6-b6d4-1dda82fab72e 36 fields · synced May 30, 2026