Cleared Traditional

Mimics Medical

K183105 · Materialise NV · Radiology
Mar 2019
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K183105 is an FDA 510(k) clearance for the Mimics Medical, 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 March 27, 2019, 139 days after receiving the submission on November 8, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K183105 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2018
Decision Date March 27, 2019
Days to Decision 139 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