Cleared Special

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

K193602 · Lv Liberty Vision Corporation · Radiology

May 2020

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K193602 is an FDA 510(k) clearance for the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Lv Liberty Vision Corporation (Portsmouth, US). The FDA issued a Cleared decision on May 29, 2020, 158 days after receiving the submission on December 23, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K193602 FDA.gov
FDA Decision	Cleared 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