# K170828: Cardiac Trigger Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: May 17, 2017 after 58 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization. Cardiac synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization. The Model 7600/7800 is intended for use in neonatal, pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals. The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality. Patient Population The Model 7600/7800 Cardiac Trigger Monitor is intended to perform ECG monitoring and R-wave pulse detection on adult, geriatric, pediatric and neonatal patients. R-wave synchronization is typically used for gating nuclear scanners, CT scanners, or other imaging devices. Contraindications The Model 7600/7800 is limited to use by trained and qualified medical professionals. This device is not intended for use as a life support or for performing cardiac diagnosis. The product is not intended for use in home care monitoring or for use in an MRI environment.

Source page: https://510kreport.com/device/K170828
Methodology: https://510kreport.com/methodology