What is FDA product code QKZ?

A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.

Gastroenterology & Urology › DiagnosticMagnetically Maneuvered Capsule Endoscopy System

NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System

Name: NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System
Brand: NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System

The NaviCam Xpress Stomach System Controller directs a magnetic capsule within the stomach during capsule endoscopy. It runs NaviCtrl software, allowing the operator to control capsule…

Registry build 21.09.26

The NaviCam Xpress Stomach System Controller directs a magnetic capsule within the stomach during capsule endoscopy. It runs NaviCtrl software, allowing the operator to control capsule position while the capsule obtains stomach images.

The NaviEC-2000 controller integrates the console and a touchscreen. An anti-collision sensor detects potential contact with a person or object. Images are reviewed separately using ESView software on a computer or laptop.

Listed Item

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

System Compatibility and Patients

The controller is used as part of the NaviCam Xpress Stomach System with its ingestible capsule and data recorder. The system is intended for stomach visualization in adults aged 22 or older with a body mass index below 38, in clinics or hospitals, including emergency departments.

2manufacturers in China registered for this device type

1catalogue number

6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Hubei (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code QKZ
Manufacturer	City	Province	Registered as	Device types
Ankon Technologies Co., Ltd.	Wuhan	Hubei	Contract manufacturer	2
Ankon Medical Technologies (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	2

Record

Regulatory record for NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System
Listed by	ANX Robotica Corp., United States
FDA product code	QKZ
Device type	Magnetically Maneuvered Capsule Endoscopy System
Device class	Class 2
Regulation	21 CFR 876.1310
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K203192
Record published	2023-01-05

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System
Catalogue number	Size	Status
Controller/ NaviEC-2000		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
NaviCam Capsule Endoscope System	ANX Robotica Corp.	3
NaviCam Stomach System	ANX Robotica Corp.	1
NaviCam Tether	ANX Robotica Corp.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241934	2024-07-31
K231960	2023-10-03
K230694	2023-04-13
K221608	2022-11-22
K203192	2021-05-04
DEN190037	2020-05-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.