510(k) K213523
K213523 is an FDA 510(k) premarket notification submitted by Alpinion Medical Systems Co., Ltd. for the device "X-CUBE i8, X-CUBE i9". The FDA issued a decision of Substantially Equivalent on Jan 28, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Alpinion Medical Systems Co., Ltd. has 25 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 28, 2022
- Date Received
- Nov 3, 2021
- 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
- 510(k)