510(k) K163574

Multi Modality Viewer by Vital Images, Inc. — Product Code LLZ

K163574 is an FDA 510(k) premarket notification submitted by Vital Images, Inc. for the device "Multi Modality Viewer". The FDA issued a decision of Substantially Equivalent on January 26, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Vital Images, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2017
Date Received
December 19, 2016
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