# K091358: Ecscope 100

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys, Inc.
- Decided: May 28, 2009 after 20 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072353: Portable Ecscope, Dyansys Corp (2007) Summary page 1.
- K080036: Portable Ecscope 12I, Dyansys, Inc. (2008) Summary page 1.
- K032200: Elan Digital 12 Channel Electrocardiograph, Remco Italia S.P.A. (2003) Summary page 1.

## Indications for use
ECScope 100 hand held, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 100 will acquire and record 12 ECG leads simultaneously. ECScope 100 is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for a specific clinical diagnosis. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.

Source page: https://510kreport.com/device/K091358
Methodology: https://510kreport.com/methodology