Cleared Traditional

Mimics inPrint

K173619 · Materialise NV · Radiology
Mar 2018
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K173619 is an FDA 510(k) clearance for the Mimics inPrint, 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 21, 2018, 119 days after receiving the submission on November 22, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K173619 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2017
Decision Date March 21, 2018
Days to Decision 119 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