Cleared Traditional

K142647 - mint Lesion

K142647 is an FDA 510(k) clearance for mint Lesion, manufactured by Mint Medical GmbH. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K142647 · Mint Medical GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
208d
Days
Class 2
Risk

K142647 is an FDA 510(k) clearance for the mint Lesion. 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 Mint Medical GmbH (Dossenheim, DE). The FDA issued a Cleared decision on April 13, 2015 after a review of 208 days - an extended review 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-to-high 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.

FDA 510(k) Submission Details - K142647

510(k) Number K142647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2014
Decision Date April 13, 2015
Days to Decision 208 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
101d slower than avg
Panel avg: 107d · This submission: 208d
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 Consultant

Mint Medical, Inc.
Matthew Steven

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2230
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K142647.
Visage Ease Pro
K142196 · Visage Imaging GmbH · Apr 2015
syngo®.via (version VB10A)
K150843 · Siemens AG · Apr 2015
SCANIP
K142779 · Simpleware , Ltd. · Apr 2015
VitreaView
K150738 · Vital Images, Inc. · Apr 2015
EzDent-i /E2/Prora View
K150747 · LK Consulting Group USA, Inc. · Apr 2015
Scenium
K150192 · Siemens Medical Solutions USA, Inc. · Mar 2015