Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016544248

FEI Number

3016544248

Entity Name

ANX ROBOTICA CORP.

City/State/Country

Plano, TX, US

Establishment Address

6010 W. Spring Creek Pkwy, Plano, TX 75024, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

AnX Robotica Corp. (Owner Number: 10062363)

Owner / Operator Contact Address

6010 W. Spring Creek Pkwy, Plano, TX 75024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221590

PMA Number

N/A

All Registered Proprietary Names

NaviCam Xpress with GastroScan NaviCam Xpress Stomach Capsule Endoscope System NaviCam Xpress Stomach System NaviCam Xpress System NaviCam Tether NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether IntraMarX 3D Radiopaque Marker MotiliCap GI Monitoring System ProScan AI Software NaviCam Xpress - 915 MHz Capsule NaviCam Stomach System NaviCam Capsule Endoscope System with NaviCam Stomach Capsule NaviCam Xpress - Lower Age Higher BMI Indication NaviCam Small Bowel Capsule Endoscopy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	Class 2	876.1310	2025-12-29
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	Class 2	876.1310	2021-05-12
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	Class 2	876.1310	2022-12-14
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2020-05-25
NYV	Gastrointestinal Motility System, Capsule	Gastroenterology, Urology	Class 2	876.1725	2025-12-29
QZF	Gastrointestinal Capsule Endoscopy Analysis Software Device	Gastroenterology, Urology	Class 2	876.1540	2025-12-29
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	Class 2	876.1310	2025-12-29
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	Class 2	876.1310	2020-05-25
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	Class 2	876.1310	2025-12-29
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	Class 2	876.1300	2023-01-13

Official Correspondent

Tim Thomas

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AnX Robotica Corp.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016544248. Last updated year: 2026. Please use registration number 3016544248 when referencing this establishment in official correspondence.