# K260343: Carescape Canvas 1000; Carescape Canvas Smart Display

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Aug 28, 2026 after 207 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K000815 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223531: CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01), GE Healthcare Finland Oy (2023) Summary page 8.

## Indications for use
Carescape Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. Carescape Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time. Carescape Canvas 1000 is indicated for monitoring of: • hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), • respiratory (impedance respiration, airway gases (CO2, 02, N20O, and anesthetic agents), spirometry, gas exchange), and • neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). Carescape Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. Carescape Canvas 1000 also shows alarms from other ECG sources. Carescape Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. Carescape Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. Carescape Canvas 1000 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Carescape Canvas 1000 is not intended for use in a controlled MRI environment. Carescape Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. Carescape Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time. Carescape Canvas Smart Display is indicated for monitoring of: • hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and • respiratory (impedance respiration, airway gases (CO2) Carescape Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular tibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. Carescape Canvas Smart Display also shows alarms from other ECG sources. Carescape Canvas Smart Display also provides other alarms, trends, snapshots and events. Carescape Canvas Smart Display can use Carescape ONE or Carescape Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. Carescape Canvas Smart Display is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Carescape Canvas Smart Display is not intended for use in a controlled MRI environment.

Source page: https://510kreport.com/device/K260343
Methodology: https://510kreport.com/methodology