# K120865: Rscribe Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Mortara Instrument, Inc.
- Decided: Jul 19, 2012 after 119 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933143 (1994). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093339: Eli PC Electrocardiograph, Mortara Instrument, Inc. (2010) Summary page 1.
- K100127: Eli 230 Electrocardiograph, Mortara Instrument, Inc. (2010)

## Most influential descendants
- K260250: QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (2026), 0 descendants of its own
- K160746: CARDIOLINE touchECG (2016), 0 descendants of its own

## Recalls of this device
- Oct 11, 2024 · Class II · Z-0322-2025: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solel

## Indications for use
The proposed Mortara RScribe Electrocardiograph is a non-invasive prescription device. * The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms. * The device is indicated for use to provide interpretation of the data for consideration by a physician. * The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. * The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. * The device is indicated for use on adult and pediatric populations. * The device is not intended to be used as a vital signs physiological monitor. * The device is not designed for out of hospital transport. * The device is not designed for use in highly invasive environments, such as an operating theatre.

Source page: https://510kreport.com/device/K120865
Methodology: https://510kreport.com/methodology