NaviCam ProScan AI Software SB-US-2-25

GUDID 00810164590275

The NaviCam ProScan AI Software is used with the NaviCam SB System with ESView to identify abnormalities of the small bowel to reduce reading time by the physician.

ANX ROBOTICA CORP

Endoscopic video image interpretive software

• Primary Device ID: 00810164590275
• NIH Device Record Key: 898ecfcb-1e21-4c53-b24e-f5dda4a3177d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NaviCam ProScan AI Software
• Version Model Number: SB-US-2025
• Catalog Number: SB-US-2-25
• Company DUNS: 024972857
• Company Name: ANX ROBOTICA CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810164590275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN230027

FDA Product Code

• QZF: Gastrointestinal Capsule Endoscopy Analysis Software Device

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: 2026-02-24
• Device Publish Date: 2026-02-16

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: 2026-02-24The NaviCam ProScan AI Software is used with the NaviCam SB System with ESView to identify abnormalities of the small bowel to reduce reading time by the physician.
• 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