Cleared Traditional

K122578 - VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING (FDA 510(k) Clearance)

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

K122578 · Vital Images, Inc. · Radiology device
Feb 2013
Decision
186d
Days
Class 2
Risk

K122578 is an FDA 510(k) clearance for the VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING. 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 February 25, 2013 after a review of 186 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.

Submission Details

510(k) Number K122578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2012
Decision Date February 25, 2013
Days to Decision 186 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 128d · This submission: 186d
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 126
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K122578.
ARTICOR planner
K252195 · Artiness S.R.L · Mar 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · Boston Scientific Corporation · Mar 2026
Aeka Imaging
K253111 · Good Methods Global, Inc. · Mar 2026
Mimics Thoracic Planner
K251964 · Materialise NV · Mar 2026
SKIA-Head (Model: SKIA-ST00)
K253486 · Skia, Inc. · Feb 2026
AS Software Version Asera
K260205 · AS Software, LLC · Feb 2026