Cleared Traditional

K141302 - VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)

K141302 is an FDA 510(k) clearance for VITREA CT MULTI-CHAMBER CARDIAC FUNCTIO..., manufactured by Vital Images, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K141302 · Vital Images, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
74d
Days
Class 2
Risk

K141302 is an FDA 510(k) clearance for the VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA). 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 August 1, 2014 after a review of 74 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

FDA 510(k) Submission Details - K141302

510(k) Number K141302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2014
Decision Date August 01, 2014
Days to Decision 74 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
33d faster than avg
Panel avg: 107d · This submission: 74d
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 1724
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K141302.
CVI42
K141480 · Circle Cardiovascular Imaging, Inc. · Aug 2014
ORTOMED
K131348 · Infomed Servicios Informaticos S.L. · Aug 2014
REMOTEYE VIEWER
K141061 · Neologica S.R.L. · Aug 2014
ENDOSIZE
K141475 · Therenva Sas · Jul 2014
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
K140897 · Siemens Medical Solutions USA, Inc. · Jul 2014
ESIE APPS SUITE
K141554 · Siemens Medical Solutions USA, Inc. · Jul 2014