Cleared Traditional

Materialise Mimics Enlight

K190874 · Materialise NV · Radiology
Jun 2019
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K190874 is an FDA 510(k) clearance for the Materialise Mimics Enlight, 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 5, 2019, 62 days after receiving the submission on April 4, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K190874 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2019
Decision Date June 05, 2019
Days to Decision 62 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