510(k) K243298
K243298 is an FDA 510(k) premarket notification submitted by Carbon (Shenzhen) Medical Device Co., Ltd. for the device "Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Apr 3, 2025. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Carbon (Shenzhen) Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 3, 2025
- Date Received
- Oct 18, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type