Cleared Traditional

K140713 - PLANMECA ROMEXIS

K140713 is the FDA 510(k) clearance for PLANMECA ROMEXIS by Planmeca Oy. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

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

K140713 is an FDA 510(k) clearance for the PLANMECA ROMEXIS. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on June 16, 2014 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Planmeca Oy devices

Submission Details

510(k) Number K140713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1057
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K140713.
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
K140897 · Siemens Medical Solutions USA, Inc. · Jul 2014
ESIE APPS SUITE
K141554 · Siemens Medical Solutions USA, Inc. · Jul 2014
QUENTRY DOSE REVIEW
K141199 · Brainlab AG · Jun 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K140960 · Hologic, Inc. · Jun 2014
VITREA IMAGE DENOISING SOFTWARE
K140395 · Vital Images, Inc. · May 2014
Q-STATION
K140808 · Philips Ultrasound, Inc. · Apr 2014