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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.

mobile electron linear accelerator for intra-operative radiotherapy (IORT)

This document is an FDA 510(k) clearance letter for a medical device. It does not contain any information about the acceptance criteria or a study proving the device meets those criteria, nor does it contain information about AI/ML performance.

The letter confirms that the device, LIAC (Models: 10MeV and 12MeV), is substantially equivalent to legally marketed predicate devices and can be marketed. It outlines the indications for use of the device, which is a mobile electron linear accelerator for intra-operative radiotherapy (IORT), meaning it delivers high doses of radiation directly aimed at tumors or other sites during surgery after a neoplasm has been removed.

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