Cleared Traditional

K142048 - EMPRINT PROCEDURE PLANNING APPLICATION

K142048 is an FDA 510(k) clearance for EMPRINT PROCEDURE PLANNING APPLICATION, manufactured by Covidien, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K142048 · Covidien, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
51d
Days
Class 2
Risk

K142048 is an FDA 510(k) clearance for the EMPRINT PROCEDURE PLANNING APPLICATION. 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 Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on September 17, 2014 after a review of 51 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 Covidien, LLC devices

FDA 510(k) Submission Details - K142048

510(k) Number K142048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2014
Decision Date September 17, 2014
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 1914
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K142048.
SURGIMAP
K141669 · Nemaris, Inc. · Sep 2014
EBM IDO VIEWER
K140399 · Ebm Technologies USA, LLC · Sep 2014
DENTAL IMAGING SOFTWARE
K141607 · Trophy · Sep 2014
STEREOS WORKSTATION
K141137 · Eos Imaging · Sep 2014
SYNAPSE 3D TENSOR ANALYSIS
K141514 · Fujifilm Meidcal Systems U.S.A.,Inc. · Sep 2014
CLIMB MAMMOGRAPHY VIEWER SOFTWARE
K141364 · Climb Medical Systems, Inc. · Aug 2014