510(k) K173962

Viamo c100 TUS-VC100 Diagnostic Ultrasound System by Toshibamedical Systems Corporation — Product Code IYN

K173962 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Viamo c100 TUS-VC100 Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Apr 20, 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
Apr 20, 2018
Date Received
Dec 28, 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)