510(k) K210468
K210468 is an FDA 510(k) premarket notification submitted by Fcu Co., Ltd. for the device "SC1 Handheld Ultrasound Imaging System (Model: SC1)". The FDA issued a decision of Substantially Equivalent on July 23, 2021. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Fcu Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2021
- Date Received
- February 16, 2021
- 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