Cleared Traditional

GIQuant (K211356) - FDA 510(k) Clearance

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

K211356 · Motilent, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
189d
Days
Class 2
Risk

K211356 is an FDA 510(k) clearance for the GIQuant. 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 Motilent, Ltd. (London, GB). The FDA issued a Cleared decision on November 8, 2021 after a review of 189 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 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 Motilent, Ltd. devices

Submission Details

510(k) Number K211356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date November 08, 2021
Days to Decision 189 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
82d slower than avg
Panel avg: 107d · This submission: 189d
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 797
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K211356.
MiPACS HTML5 Web Viewer
K212984 · Lead Technologies, Inc. · Nov 2021
inVisionOS
K210344 · Precisionos Technology, Inc. · Nov 2021
RTapp
K212887 · Segana, Inc. · Nov 2021
Hura CTP v1.0
K212550 · Hura Imaging, Inc. · Nov 2021
Visible Patient Suite
K212896 · Visible Patient, Sas · Nov 2021
VisionX 3.0
K213326 · Durr Dental SE · Nov 2021