510(k) K251071
K251071 is an FDA 510(k) premarket notification submitted by Brightheart for the device "Fetal EchoScan (v1.1)". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer), a Class II device regulated under 21 CFR 892.2060. Brightheart has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2025
- Date Received
- April 7, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- Device Class
- Class II
- Regulation Number
- 892.2060
- Review Panel
- RA
- Submission Type
Assist users in characterizing lesions identified on acquired medical images