510(k) K211156

CONVIVO In Vivo Pathology Suite by Carl Zeiss Meditec, AG — Product Code LLZ

K211156 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, AG for the device "CONVIVO In Vivo Pathology Suite". The FDA issued a decision of Substantially Equivalent on December 29, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Carl Zeiss Meditec, AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2021
Date Received
April 19, 2021
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