Cleared Traditional

SurgiCase Viewer

K213684 · Materialise NV · Radiology
Jun 2022
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K213684 is an FDA 510(k) clearance for the SurgiCase Viewer, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on June 15, 2022, 205 days after receiving the submission on November 22, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K213684 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2021
Decision Date June 15, 2022
Days to Decision 205 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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