NaviCam Capsule Endoscope System

FDA UDI

Class II (US FDA UDI)

by Anx Robotica Corp.

Identity

Trade Name: NaviCam Capsule Endoscope System FDA UDI
Generic Name: Video capsule endoscopy system capsule FDA UDI
Device Name: The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel 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 to be controlled by an operator. FDA UDI
Model / Reference: Stomach Capsule/AKEM-11SW FDA UDI
Description: The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel 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 to be controlled by an operator. FDA UDI

Identifiers

Catalog Number: CP-US-7006 FDA UDI
Primary DI / UDI-DI: 00850015518195 FDA UDI
510(k) Number: DEN190037 FDA UDI
FDA Product Code: QKZ FDA UDI
GMDN Term: Video capsule endoscopy system capsule 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Video capsule endoscopy system capsule

NaviCam Capsule Endoscope System by Anx Robotica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Video capsule endoscopy system capsule.

MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
PillCam — Given Imaging , Ltd. · Class II
Pillcam — Given Imaging , Ltd. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
Pillcam — Given Imaging , Ltd. · Class II
PillCam — Given Imaging , Ltd. · Class II
PillCam — Given Imaging , Ltd. · Class II

Cleared under the same submission

DEN190037 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 c8f817da-533e-46b3-8b76-56f17612f750 35 fields · synced Jun 6, 2026