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510(k) Data Aggregation
K Number
K170154Device Name
Creavo Vitalscan Magnetocardiograph
Manufacturer
Creavo Medical Technologies, Ltd.
Date Cleared
2017-10-12
(267 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Creavo Medical Technologies, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Creavo Vitalscan Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
Device Description
The Creavo Vitalscan Magnetocardiograph is a transportable device, when not in use, which includes a scan head containing multiple sensors, a moveable arm, electronics, software, user touch screen, power supply, and a rechargeable battery. The wheeled chassis and handles allow the device to be transportable between patient beds. During use, the device is placed adjacent to the patient bed. The color touch screen allows the user to enter patient information (e.g., patient name and scan information) and serves as the visual display unit of the numerical and graphical results during testing. The device also incorporates the use of single use standard ECG electrodes and reusable AHA patient lead wires. The ECG electrodes, are used for gating of the magnetocardiograph signal with the patient's cardiac electrical signal and are used to assist triggering the device electronics and software.
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