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510(k) Data Aggregation
K Number
K193602Device Name
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
Manufacturer
LV Liberty Vision Corporation
Date Cleared
2020-05-29
(158 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
LV Liberty Vision Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.
Device Description
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is a singly-encapsulated 99Yttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 99Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650).
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