Home GUDID 00810164590275 NaviCam ProScan AI Software
Primary DI 00810164590275
Brand NaviCam ProScan AI Software
Company ANX ROBOTICA CORP
Model SB-US-2025
Catalog number SB-US-2-25
Device description 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.
Published 2026-02-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QZF Gastrointestinal Capsule Endoscopy Analysis Software Device Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810164590275 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810164590275 00810164590275 810164590275 0810164590275
GMDN Terms# Term, Definition table Term Definition Gastrointestinal endoscopy support software A software program intended to display, analyse/process, and possibly acquire images of the gastrointestinal tract acquired by an endoscopic device (endoscope or capsule) to assist with the visual examination and treatment of a condition (e.g., polyp detection). It may be capable of differentiating lesions and/or producing a probability score (e.g., neoplastic versus non-neoplastic), and/or adjusting capsule settings [e.g., position in the gastrointestinal (GI) tract]. It does not incorporate adaptive/dynamic machine learning (ML) models.
Regulatory Flags# DUNS number 024972857 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850015518195 NaviCam Capsule Endoscope System Stomach Capsule/AKEM-11SW CP-US-7006 2020-12-08 00850015518003 IntraMarX Radiopaque Markers AGIROMC1-1(R) AGIROMC1-1(R) 2020-01-27 00850015518010 IntraMarX Radiopaque Markers AGIROMC1-1(DD) AGIROMC1-1(DD) 2020-01-27 00850015518027 IntraMarX Radiopaque Markers AGIROMC1-1(TC) AGIROMC1-1(TC) 2020-01-27 00810164590114 NaviCam Data Recorder SB-US-2003 SB-US-2003 2026-02-16 00810164590145 NaviCam Locator SB-US-2006 SB-US-2006 2026-02-16 00810164590169 NaviCam ESView Software ESView 2.X SB-US-2006 2026-02-16 00810164590794 NaviCam ESView 3.X ESView 3.X SB-US-2026 2026-02-16 00810164590633 MotiliCap GI Monitoring System Data Recorder MO-US-8001 MO-US-8001 2026-02-09 00810164590640 MotiliCap GI Monitoring System Software (MotiliScan) MO-US-8005 MO-US-8005 2026-02-09 00810164590657 MotiliCap GI Monitoring System Capsule CP-US-7010 CP-US-7010 2026-02-09 00810164590817 MotiliCap GI Monitoring System Mobile Phone/App MO-US-8010 MO-US-8010 2026-02-09 00850015518287 NaviCam Tether CEE-1 ES-US-3002 2023-01-05 00850015518294 NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System Controller/ NaviEC-2000 MC-US-1002 2023-01-05 00850015518072 NaviCam Stomach System Locator AKS-1 SB-US-2006 2020-12-08 00850015518188 NaviCam Capsule Endoscope System Recorder/AKR-1 MC-US-1006 2020-12-08 00850015518201 NaviCam Capsule Endoscope System Controller/NaviEC-1000 MC-US-1001 2020-12-08 00850015518232 IntraMarX 3D Combo 2020-12-08 00850015518126 IntraMarX AGIROMC1-1-R/1 AGIROMC1-1-R/1 2020-07-08 00850015518133 IntraMarX AGIROMC1-1-DD/1 AGIROMC1-1-DD/1 2020-07-08