# K163607: ECG Acquisition Systems

- Pathway: 510(k) (Traditional)
- Applicant: Vales & Hills Biomedical Tech., Ltd.
- Decided: Dec 15, 2017 after 359 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K942704 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150564: Spaulding Electrocardiograph 2100iQ, Spaulding Clinical Research, LLC (2015) Summary page 5.

## Indications for use
The ECG Acquisition Systems is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to vhECG Pro, which installed in iPad or iPhone. This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12-lead ECGs. The ECG Acquisition Systems is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use as a vital signs physiological monitor. The subject device is intended to be used for clinical use rather than home use. It can be used in a professional healthcare facility, or a clinical environment such as clinics. It cannot be used in transport environment, such as ambulance. The ECG Acquisition Systems provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.

Source page: https://510kreport.com/device/K163607
Methodology: https://510kreport.com/methodology