Cleared Traditional

K151919 - Vitrea CT Lung Density Analysis Software

K151919 is the FDA 510(k) clearance for Vitrea CT Lung Density Analysis Software by Vital Images, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K151919 · Vital Images, Inc. · Radiology device
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Oct 2015
Decision
89d
Days
Class 2
Risk

K151919 is an FDA 510(k) clearance for the Vitrea CT Lung Density Analysis Software. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Vital Images, Inc. (Minnetonka, US). The FDA issued a Cleared decision on October 10, 2015 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vital Images, Inc. devices

Submission Details

510(k) Number K151919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2015
Decision Date October 10, 2015
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K151919.
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K150713 · Siemens Medical Solutions USA, Inc. · Nov 2015
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K150595 · Hitachi Medical Systems America, Inc. · Oct 2015
Lung Analysis Software
K151283 · Vital Images, Inc. · Oct 2015
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K151833 · Toshibamedical Systems Corporation · Oct 2015
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
K152036 · Siemens Medical Solutions USA, Inc. · Oct 2015
Supria Whole-body X-ray CT System
K150565 · Hitachi Medical Systems America, Inc. · Sep 2015