510(k) K242496
K242496 is an FDA 510(k) premarket notification submitted by Eieling Technology (Shenzhen) Limited for the device "Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)". The FDA issued a decision of Substantially Equivalent on November 19, 2024. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Eieling Technology (Shenzhen) Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2024
- Date Received
- August 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type