B-Right Screen Fetal Heart

GUDID 03760415600000

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

BRIGHTHEART

Ultrasound imaging system application software

• Primary Device ID: 03760415600000
• NIH Device Record Key: 62ca821c-d557-407a-afeb-fb4187ef962f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-Right Screen Fetal Heart
• Version Model Number: V1.0.0
• Company DUNS: 279036039
• Company Name: BRIGHTHEART
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760415600000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242342

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-05
• Device Publish Date: 2025-01-28