# K210543: IM007

- Pathway: 510(k) (Traditional)
- Applicant: Implicity, Inc.
- Decided: Nov 3, 2021 after 252 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003621 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170568: CardioLogs ECG Analysis Platform, Cardiologs Technologies (2017) Summary page 5.

## Most influential descendants
- K253463: ILR ECG Analyzer (IM007) (2026), 0 descendants of its own

## Indications for use
IMO007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IMO007 supports downloading and analyzing data recorded in compatible formats from ICMs. This version of the IM007 only supports ECG data from Medtronic ICMs. IMO007 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. IMO007 provides ECG signal processing and analysis, to detect asystole, bradycardia, atrial tachycardia or atrial fibrillation, ventricular tachycardia, normal rhythm and artifact. IMO007 is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. IMO007 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.

Source page: https://510kreport.com/device/K210543
Methodology: https://510kreport.com/methodology