Cleared Traditional

Quantib Brain (K173939) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173939 · Quantib B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
73d
Days
Class 2
Risk

K173939 is an FDA 510(k) clearance for the Quantib Brain. 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 Quantib B.V. (Rotterdam, NL). The FDA issued a Cleared decision on March 9, 2018 after a review of 73 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 Quantib B.V. devices

Submission Details

510(k) Number K173939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date March 09, 2018
Days to Decision 73 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
34d faster than avg
Panel avg: 107d · This submission: 73d
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 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K173939.
syngo Application Software
K173611 · Siemens Medical Solutions USA, Inc. · Mar 2018
Imbio Segmentation Editing Tool software
K180129 · Imbio, LLC · Mar 2018
SICAT Endo
K180262 · Sicat GmbH & Co. KG · Mar 2018
BrightMatter Plan 1.6.0
K180394 · Synaptive Medical, Inc. · Mar 2018
iQMR
K173605 · Medic Vision - Imaging Solutions, Ltd. · Mar 2018
icobrain
K180326 · Icometrix · Mar 2018