Cleared Traditional

K122578 - VITREA CT TRANSCATHETER AORTIC VALVE RE...

K122578 is the FDA 510(k) clearance for VITREA CT TRANSCATHETER AORTIC VALVE RE... by Vital Images, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K122578 · Vital Images, Inc. · Radiology device
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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.

View all Vital Images, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 107d · 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

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