B-Right AI Platform is a marketing term encompassing all BrightHeart's "B-Right" solutions. 

Please check the regulatory information about each medical device.

B-Right Views Fetal Heart is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound examinations.

B-Right Views Fetal Heart is a FDA-cleared Class II medical device for use by healthcare professionals only that have been cleared by the FDA under K251456.

For more information on precise indications for use, warnings, and limitations of the device, please refer to the 510(k) summary available on the FDA's website or the instructions for use for more information.

B-Right Screen is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.

B-Right Screen is a FDA-cleared Class II medical device for use by healthcare professionals only that have been cleared by the FDA under K252294.

For more information on precise indications for use, warnings, and limitations of the device, please refer to the 510(k) summary available on the FDA's website or the instructions for use for more information.