Cleared Traditional

K192038 - Emprint Visualization Application

K192038 is the FDA 510(k) clearance for Emprint Visualization Application by Covidien, LLC. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K192038 · Covidien, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
125d
Days
Class 2
Risk

K192038 is an FDA 510(k) clearance for the Emprint Visualization 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 (Boulder, US). The FDA issued a Cleared decision on December 2, 2019 after a review of 125 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K192038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2019
Decision Date December 02, 2019
Days to Decision 125 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
18d slower than avg
Panel avg: 107d · This submission: 125d
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 1094
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K192038.
NemoScan
K192571 · Software Nemotec S.L. · Dec 2019
PhantomMSK Trauma
K192279 · OrthoGrid Systems, Inc. · Dec 2019
SICAT Implant V2.0
K192348 · Sicat GmbH & Co. KG · Dec 2019
Medsynapse Ris Pacs & Medsynapse VNA
K192508 · Medsynaptic Private, Ltd. · Nov 2019
RSI-MRI+
K191278 · Multimodal Imaging Services Corporation (Dba Healthlytix) · Nov 2019
QuantX Breast MRI Biopsy Guidance Plugin
K191959 · Qlarity Imaging · Nov 2019