Cleared Traditional

K191959 - QuantX Breast MRI Biopsy Guidance Plugin

K191959 is the FDA 510(k) clearance for QuantX Breast MRI Biopsy Guidance Plugin by Qlarity Imaging. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K191959 · Qlarity Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
108d
Days
Class 2
Risk

K191959 is an FDA 510(k) clearance for the QuantX Breast MRI Biopsy Guidance Plugin. 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 Qlarity Imaging (Chicago, US). The FDA issued a Cleared decision on November 8, 2019 after a review of 108 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 Qlarity Imaging devices

Submission Details

510(k) Number K191959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2019
Decision Date November 08, 2019
Days to Decision 108 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
1d slower than avg
Panel avg: 107d · This submission: 108d
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 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K191959.
Emprint Visualization Application
K192038 · Covidien, LLC · Dec 2019
Medsynapse Ris Pacs & Medsynapse VNA
K192508 · Medsynaptic Private, Ltd. · Nov 2019
RSI-MRI+
K191278 · Multimodal Imaging Services Corporation (Dba Healthlytix) · Nov 2019
MEDIP PRO
K191026 · Medical IP Co., Ltd. · Nov 2019
Cleerly Labs
K190868 · Cleerly, Inc. · Nov 2019
KOALA
K192109 · Ib Lab GmbH · Nov 2019