510(k) K242342
K242342 is an FDA 510(k) premarket notification submitted by Brightheart for the device "Fetal EchoScan". The FDA issued a decision of Substantially Equivalent on November 14, 2024. 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
- November 14, 2024
- Date Received
- August 7, 2024
- Clearance Type
- Traditional
- 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