Cleared Traditional

Planmeca Romexis

K200572 · Planmeca Oy · Radiology
Dec 2020
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K200572 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 December 2, 2020, 272 days after receiving the submission on March 5, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K200572 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2020
Decision Date December 02, 2020
Days to Decision 272 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