# K253463: ILR ECG Analyzer (IM007)

- Pathway: 510(k) (Traditional)
- Applicant: Implicity, Inc.
- Decided: Jul 2, 2026 after 267 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: 6 generations back to K003621 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210543: IM007, Implicity, Inc. (2021) Summary page 8.

## Indications for use
IM007 is intended for use by qualified healthcare professionals for the assessment of arrhythmias in Insertable Cardiac Monitor (ICM) ECG data. IM007 supports analyzing data recorded in compatible formats from ICMs. This version of IM007 supports ECG data from compatible Abbott, Biotronik, Boston Scientific and Medtronic ICMs. The device is intended for use in adult patients (18 years and older) who have been implanted with a compatible ICM for diagnosis or monitoring of cardiac arrhythmias. 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 analysis to differentiate normal rhythm from abnormalities. IM007 is not for use in life-supporting or life-sustaining systems or ECG monitors and alarm devices. IM007 interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and healthcare professionals on an advisory basis only, in conjunction with the clinical knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

Source page: https://510kreport.com/device/K253463
Methodology: https://510kreport.com/methodology