Cleared Special

K193602 - LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

K193602 is an FDA 510(k) clearance for LV Liberty Vision Model 1 90Yttrium Bra..., manufactured by Lv Liberty Vision Corporation. The device is a Class 2 Radiology device with product code KXK cleared through the Special 510(k) pathway after a 158-day FDA review.

K193602 · Lv Liberty Vision Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
158d
Days
Class 2
Risk

K193602 is an FDA 510(k) clearance for the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Lv Liberty Vision Corporation (Portsmouth, US). The FDA issued a Cleared decision on May 29, 2020 after a review of 158 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K193602

510(k) Number K193602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date May 29, 2020
Days to Decision 158 days
Submission Type Special
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
51d slower than avg
Panel avg: 107d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

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 150
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K193602 · LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
Download PDF FDA Summary Lv Liberty Vision Cor…