Cleared Traditional

K153351 - Quantib Brain 1

K153351 is an FDA 510(k) clearance for Quantib Brain 1, manufactured by Quantib B.V.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K153351 · Quantib B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
210d
Days
Class 2
Risk

K153351 is an FDA 510(k) clearance for the Quantib Brain 1. 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 June 17, 2016 after a review of 210 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.

View all Quantib B.V. devices

FDA 510(k) Submission Details - K153351

510(k) Number K153351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date June 17, 2016
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 107d · This submission: 210d
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 1204
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K153351.
Multi Modality Viewer
K161419 · Vital Images, Inc. · Jul 2016
syngo®.via protoNeo (Version VA10A)
K161685 · Siemens Healthcare GmbH · Jul 2016
IMPAX Volume Viewing 4.0
K161061 · Agfa Healthcare N.V. · Jun 2016
Ez3D-i / E3
K161246 · Ewoosoft Co., Ltd. · May 2016
3mensio Workstation
K153736 · Pie Medical Imaging BV · May 2016
EzDent-i / E2 / Prora View
K161117 · Ewoosoft Co., Ltd. · May 2016