# K182374: LIAC S

- Pathway: 510(k) (Traditional)
- Applicant: Sit Sordina Iort Technologies Spa
- Decided: May 22, 2019 after 264 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K852907 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172961: Liac HWL, Sit Sordina Iort Technologies Spa (2018) Summary page 5.

## Indications for use
LIAC S is 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 S is meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The devices must be sold by or on the order of a physician. The device is not for use by the general public or over-the-counter. LIAC S is an electron accelerator that can work in an operating theatre respecting its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.

Source page: https://510kreport.com/device/K182374
Methodology: https://510kreport.com/methodology