Cleared Traditional

K201092 - LSN

K201092 is the FDA 510(k) clearance for LSN by Imaging Biometrics, LLC. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K201092 · Imaging Biometrics, LLC · Radiology device
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Oct 2020
Decision
189d
Days
Class 2
Risk

K201092 is an FDA 510(k) clearance for the LSN. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Imaging Biometrics, LLC (Elm Grove, US). The FDA issued a Cleared decision on October 29, 2020 after a review of 189 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 Imaging Biometrics, LLC devices

Submission Details

510(k) Number K201092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2020
Decision Date October 29, 2020
Days to Decision 189 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
82d slower than avg
Panel avg: 107d · This submission: 189d
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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