510(k) K172855

Vitrea Advanced Visualization, Version 7.6 by Vital Images, Inc. — Product Code LLZ

K172855 is an FDA 510(k) premarket notification submitted by Vital Images, Inc. for the device "Vitrea Advanced Visualization, Version 7.6". The FDA issued a decision of Substantially Equivalent on October 5, 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
October 5, 2017
Date Received
September 20, 2017
Clearance Type
Special
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