# K091397: Ecscope 200

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys, Inc.
- Decided: Jul 8, 2009 after 57 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: 5 generations back to K895520 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070614: Corscreen, Viasys Healthcare GmbH (2007) Summary page 1.
- K002074: AB Cardiette Daedalus View Base and AB Cardiettte Daedalus View Hes, H&C Medical Devices Spa (2000) Summary page 1.
- K080036: Portable Ecscope 12I, Dyansys, Inc. (2008) Summary page 1.

## Indications for use
ECScope 200 portable, battery operated 12 channel electrocardiographs is intended to be used for the diagnosis of cardiovascular system complications. ECScope 200 will acquire and record 12 ECG leads simultaneously. The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm. Interpretation results must be overviewed and approved by trained physicians. Interpretation just represents partial qualitative and quantitative information of the general patient cardiovascular conditions. No therapy or drugs can be administered based solely on the interpretation statements. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of the patient, the results of physical examination and other clinical findings. The equipments are intended to be used by trained medical personnel or physicians.

Source page: https://510kreport.com/device/K091397
Methodology: https://510kreport.com/methodology