Cleared Traditional

CONVIVO In Vivo Pathology Suite

K211156 · Carl Zeiss Meditec, AG · Neurology
Dec 2021
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K211156 is an FDA 510(k) clearance for the CONVIVO In Vivo Pathology Suite, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on December 29, 2021, 254 days after receiving the submission on April 19, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K211156 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2021
Decision Date December 29, 2021
Days to Decision 254 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050