Cleared Traditional

K163572 - LV Liberty Vision Model 1 90 Yttrium Br...

K163572 is an FDA 510(k) clearance for LV Liberty Vision Model 1 90 Yttrium Br..., manufactured by Lv Liberty Vision Corp.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K163572 · Lv Liberty Vision Corp. · Radiology device
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Mar 2017
Decision
86d
Days
Class 2
Risk

K163572 is an FDA 510(k) clearance for the LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Lv Liberty Vision Corp. (Portsmouth, US). The FDA issued a Cleared decision on March 15, 2017 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Lv Liberty Vision Corp. devices

FDA 510(k) Submission Details - K163572

510(k) Number K163572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date March 15, 2017
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 33
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K163572.
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K103449 · Riverpoint Medical · Feb 2011