510(k) K163702
K163702 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1". The FDA issued a decision of Substantially Equivalent on May 30, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2017
- Date Received
- Dec 29, 2016
- 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)