Cleared Traditional

K140713 - PLANMECA ROMEXIS
(FDA 510(k) Clearance)

K140713 · Planmeca Oy · Radiology
Jun 2014
Decision
87d
Days
Class 2
Risk

K140713 is an FDA 510(k) clearance for the PLANMECA ROMEXIS. This device is classified as 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 June 16, 2014, 87 days after receiving the submission on March 21, 2014.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K140713 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2014
Decision Date June 16, 2014
Days to Decision 87 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