Cleared Traditional

K151283 - Lung Analysis Software

K151283 is an FDA 510(k) clearance for Lung Analysis Software, manufactured by Vital Images, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K151283 · Vital Images, Inc. · Radiology device
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Oct 2015
Decision
169d
Days
Class 2
Risk

K151283 is an FDA 510(k) clearance for the Lung 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 30, 2015 after a review of 169 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

FDA 510(k) Submission Details - K151283

510(k) Number K151283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2015
Decision Date October 30, 2015
Days to Decision 169 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
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 713
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K151283.
NeuViz 128 Multi-slice CT Scanner System
K151383 · Neusoft Medical Systems Co., Ltd. · Nov 2015
syngo.CT Myocardial Perfusion
K150713 · Siemens Medical Solutions USA, Inc. · Nov 2015
SCENARIA Phase 3 Whole-body X-ray CT System
K150595 · Hitachi Medical Systems America, Inc. · Oct 2015
Vitrea CT Lung Density Analysis Software
K151919 · Vital Images, Inc. · Oct 2015
Aquilion Lightning (TSX-035A/2, V7.0)
K151833 · Toshibamedical Systems Corporation · Oct 2015
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
K152036 · Siemens Medical Solutions USA, Inc. · Oct 2015