# K152944: Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Jan 6, 2016 after 92 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900720 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022618: X-Scribe II, Mortara Instrument, Inc. (2002) Summary page 5.

## Recalls of this device
- Oct 11, 2024 · Class II · Z-0321-2025: 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
- Oct 11, 2024 · Class II · Z-0325-2025: 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
- Dec 8, 2023 · Class II · Z-0705-2024: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
- Dec 8, 2023 · Class II · Z-0706-2024: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
- Mar 18, 2020 · Class II · Z-1817-2020: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

## Indications for use
The XScribe/Q-Stress device is intended to acquire, process, record, archive, analyze, and output electrocardiographic data during physiologic stress testing. The device is intended for use in adult, adolescent, and children patient populations. The device is intended for use in a clinical setting by trained personnel under the supervision of a licensed physician. The device may interface with equipment for pulmonary function testing and other devices, including a treadmill or ergometer for dynamic exercise evaluation, as well as non- invasive blood pressure equipment, functional arterial oxygen saturation (SpO2) equipment, and computer communications equipment. The device is not intended to be used as a vital signs physiological monitor.

Source page: https://510kreport.com/device/K152944
Methodology: https://510kreport.com/methodology