# K031466: Iqmark Digital Holter

- Pathway: 510(k) (Special)
- Applicant: Brentwood Medical Technology Corp.
- Decided: Jun 11, 2003 after 34 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871344 (1987). 10 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914577: Rhythmscan Precision 6000, Precision Health Care Systems, Inc. (1992) Summary page 1.
- K990727: Syneflash & Syneview, Ela Medical, Inc. (1999) Summary page 1.

## Most influential descendants
- K063035: Sleuth Implantable Ecg Monitoring System (2007), 3 descendants of its own
- K073147: Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08 (2007), 2 descendants of its own
- K083828: Sleuth at Implantable Cardiac Monitoring System -6 CM  and 8CM Antenna, Personal Diagnostics Manager (PDM) Accessory Kit (2009), 1 descendant of its own
- K142693: ZywieAI Software Library (2015), 0 descendants of its own
- K091206: Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic Manager (PDM) Accessory Kit, Model (2009), 0 descendants of its own

## Indications for use
The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report. The IQmark Digital Holter is intended to be used only by physicians or on the order of a physician. The intended use of the IQmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577).

Source page: https://510kreport.com/device/K031466
Methodology: https://510kreport.com/methodology