GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

Primary DI

03770025266008

Basic UDI-DI Code

B-03770025266008

Reference

IM007

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Implicity

The indications for use of the IM007 software module is provided below. IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IM007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs. IM007 is intended to be electronically interfaced with other computer systems (remote monitoring platform) that supply the ECG data to IM007, and receive the output of IM007 (analysis) for viewing by the healthcare professionals. IM007 provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact. IM007 is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. IM007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDD).