510(k) K173090
K173090 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4". The FDA issued a decision of Substantially Equivalent on Jan 11, 2018. 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
- Jan 11, 2018
- Date Received
- Sep 29, 2017
- 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)