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

• Primary Device ID: 00850015518195
• NIH Device Record Key: c8f817da-533e-46b3-8b76-56f17612f750
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviCam Capsule Endoscope System
• Version Model Number: Stomach Capsule/AKEM-11SW
• Company DUNS: 024972857
• Company Name: ANX ROBOTICA CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015518195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190037

FDA Product Code

• QKZ: Magnetically Maneuvered Capsule Endoscopy System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-16
• Device Publish Date: 2020-12-08

On-Brand Devices [NaviCam Capsule Endoscope System]

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