NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System MC-US-1002

GUDID 00850015518294

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

ANX ROBOTICA CORP

Video capsule endoscopy system capsule magnetic manipulation unit

• Primary Device ID: 00850015518294
• NIH Device Record Key: ae94ceab-09c4-41f6-b6d4-1dda82fab72e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System
• Version Model Number: Controller/ NaviEC-2000
• Catalog Number: MC-US-1002
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 770-480-2911
• Email: tim.thomas@anxrobotics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015518294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203192

FDA Product Code

• QKZ: Magnetically Maneuvered Capsule Endoscopy System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-13
• Device Publish Date: 2023-01-05

Devices Manufactured by ANX ROBOTICA CORP

• 00810164590114 - NaviCam Data Recorder: 2026-02-24
• 00810164590145 - NaviCam Locator: 2026-02-24 The NaviCam Locator is used to activate the NaviCam SB capsules and may also be used to determine if the capsule is still within
• 00810164590169 - NaviCam ESView Software: 2026-02-24 The ESView software is used with the NaviCam SB System to analyze the images and create a video for the physician to review afte
• 00810164590275 - NaviCam ProScan AI Software: 2026-02-24 The NaviCam ProScan AI Software is used with the NaviCam SB System with ESView to identify abnormalities of the small bowel to r
• 00810164590794 - NaviCam ESView 3.X: 2026-02-24 The NaviCam ESView 3.X software is used with the NaviCam SB System to analyze images to create a video for the physician to revi
• 00810164590008 - NaviCam SB Capsule: 2026-02-17 NaviCam SB Capsule is a gastrointestinal capsule endoscope used with the NaviCam SB Capsule Endoscope System to visualize the sm
• 00810164590039 - NaviCam SB Capsule/Tether: 2026-02-17 The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before rele
• 00810164590633 - MotiliCap GI Monitoring System Data Recorder: 2026-02-17 The MotiliCap Data Recorder is used with the MotiliCap GI Monitoring System to receive and store transmitted data from the Motil