Cleared Traditional

K161157 - Vitrea CT Dual Energy Image View

K161157 is the FDA 510(k) clearance for Vitrea CT Dual Energy Image View by Vital Images, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K161157 · Vital Images, Inc. · Radiology device
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Nov 2016
Decision
192d
Days
Class 2
Risk

K161157 is an FDA 510(k) clearance for the Vitrea CT Dual Energy Image View. 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 November 3, 2016 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vital Images, Inc. devices

Submission Details

510(k) Number K161157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2016
Decision Date November 03, 2016
Days to Decision 192 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
85d slower than avg
Panel avg: 107d · This submission: 192d
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
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