510(k) K173088

Vitrea Software Toshiba Package VSTP-001A by Toshibamedical Systems Corporation — Product Code LLZ

K173088 is an FDA 510(k) premarket notification submitted by Toshibamedical Systems Corporation for the device "Vitrea Software Toshiba Package VSTP-001A". The FDA issued a decision of Substantially Equivalent on Jan 31, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Toshibamedical Systems Corporation has 79 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 31, 2018
Date Received
Sep 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type
510(k)