# K080036: Portable Ecscope 12I

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys, Inc.
- Decided: Jan 16, 2008 after 9 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: 4 generations back to K895520 (1990). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 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.
- K954980: Pagewriter 200, 200I Cardiograph & Interpretive Cardio, Hewlett-Packard Co. (1996) Summary page 1.
- K032200: Elan Digital 12 Channel Electrocardiograph, Remco Italia S.P.A. (2003) Summary page 1.

## Most influential descendants
- K091397: Ecscope 200 (2009), 0 descendants of its own
- K091358: Ecscope 100 (2009), 0 descendants of its own

## Indications for use
Portable ECScope 12i hand held, battery operated 12 channel electrocardiograph is intended to be used for the evaluation of the cardiovascular system. Portable ECScope 12i will acquire, record 12 ECG leads simultaneously and display 3 leads in its display unit. Portable ECScope 12i 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/K080036
Methodology: https://510kreport.com/methodology