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510(k) Data Aggregation
K Number
K110840Device Name
LIAC
Manufacturer
Date Cleared
2012-04-17
(389 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SORDINA S.P.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Liac (Models: 10MeV and 12MeV) is a mobile electron linear accelerator for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites. The LIAC is meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The device must be sold by or on the order of a physician. It is not for use by the general public or over-the-counter.
Device Description
mobile electron linear accelerator for intra-operative radiotherapy (IORT)
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