NaviCam Capsule Endoscope System

GUDID 00850015518195

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.

ANX ROBOTICA CORP

Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule Video capsule endoscopy system capsule
Primary Device ID00850015518195
NIH Device Record Keyc8f817da-533e-46b3-8b76-56f17612f750
Commercial Distribution StatusIn Commercial Distribution
Brand NameNaviCam Capsule Endoscope System
Version Model NumberStomach Capsule/AKEM-11SW
Company DUNS024972857
Company NameANX ROBOTICA CORP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015518195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QKZMagnetically Maneuvered Capsule Endoscopy System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-16
Device Publish Date2020-12-08

On-Brand Devices [NaviCam Capsule Endoscope System]

00850015518201Controller. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomac
00850015518195The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System”
00850015518188DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Sto

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.