Cleared Traditional

Planmeca Romexis

K171385 · Planmeca Oy · Radiology
Nov 2017
Decision
187d
Days
Class 2
Risk

About This 510(k) Submission

K171385 is an FDA 510(k) clearance for the Planmeca Romexis, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on November 14, 2017, 187 days after receiving the submission on May 11, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K171385 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2017
Decision Date November 14, 2017
Days to Decision 187 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