Cleared Special

K140445 - DEXIS SOFTWARE: DEXIS IMAGING SUITE

K140445 is an FDA 510(k) clearance for DEXIS SOFTWARE: DEXIS IMAGING SUITE, manufactured by Imaging Sciences International, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 61-day FDA review.

K140445 · Imaging Sciences International, LLC · Radiology device
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Apr 2014
Decision
61d
Days
Class 2
Risk

K140445 is an FDA 510(k) clearance for the DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC. 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 Imaging Sciences International, LLC (Hatfield, US). The FDA issued a Cleared decision on April 23, 2014 after a review of 61 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Imaging Sciences International, LLC devices

FDA 510(k) Submission Details - K140445

510(k) Number K140445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2014
Decision Date April 23, 2014
Days to Decision 61 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 107d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

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 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K140445.
PLANMECA ROMEXIS
K140713 · Planmeca Oy · Jun 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K140960 · Hologic, Inc. · Jun 2014
VITREA IMAGE DENOISING SOFTWARE
K140395 · Vital Images, Inc. · May 2014
Q-STATION
K140808 · Philips Ultrasound, Inc. · Apr 2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
K140271 · Carestream Health, Inc. · Apr 2014
CORONIS 5MP
K133984 · Barco N.V. · Mar 2014