GASTROINTESTINAL IMAGING DIAGNOSTIC DEVICES

Primary DI

00867770000261

Basic UDI-DI Code

086777000026SV3KITBT

Reference

CapsoCam Plus

Device Types

Single use

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

CapsoVision, Inc.

CapsoCam Plus SV-3 video capsule is a single-use ingestible capsule system for diagnostic visualization of the adult small bowel. The overall system consists of an ingestible capsule the CapsoRetrieve® (CVR1) Capsule Retrieval Kit, the CapsoAccess® Capsule Data Access System (CDAS) and the CapsoView® (CVV) software. The capsule contains a panoramic color digital video camera, two silver-oxide watch batteries, white-LED light sources, a laser diode for data download, and system-control and nonvolatile flash-memory data-storage electronics. The CapsoCam Plus has four side-facing cameras arrayed around the circumference of the capsule that together image a 360º circumference and capture high-resolution color images of the mucosa. As it passes through the gastrointestinal tract under natural peristaltic movement, the capsule captures and saves images and other data in the on-board flash memory. The patient collects the capsule after it is excreted using the retrieval system, and returns it per the physician’s instruction. At the clinic that capsule is placed in a data acquisition system where the video data is downloaded from the capsule to a workstation. Custom workstation software (CVV) allows the physician to review and interpret the downloaded video images, make a diagnosis, and create a report.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).