Cleared Traditional

K140395 - VITREA IMAGE DENOISING SOFTWARE

K140395 is the FDA 510(k) clearance for VITREA IMAGE DENOISING SOFTWARE by Vital Images, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K140395 · Vital Images, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
84d
Days
Class 2
Risk

K140395 is an FDA 510(k) clearance for the VITREA IMAGE DENOISING SOFTWARE. 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 Vital Images, Inc. (Minnetonka, US). The FDA issued a Cleared decision on May 13, 2014 after a review of 84 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 Vital Images, Inc. devices

Submission Details

510(k) Number K140395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2014
Decision Date May 13, 2014
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 1055
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K140395.
ESIE APPS SUITE
K141554 · Siemens Medical Solutions USA, Inc. · Jul 2014
QUENTRY DOSE REVIEW
K141199 · Brainlab AG · Jun 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K140960 · Hologic, Inc. · Jun 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