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B-Right Screen Fetal Heart
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
Details
Device typeUltrasound imaging system application software: "An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and ""version"" or ""upgrade"" number."
FDA categoryComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Device ID03760415600000
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information