510(k) K091518
K091518 is an FDA 510(k) premarket notification submitted by Mcube Technology Co., Ltd. for the device "CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 18, 2009. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Mcube Technology Co., Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 18, 2009
- Date Received
- May 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Echo, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- RA
- Submission Type
- 510(k)