# K172961: Liac HWL

- Pathway: 510(k) (Traditional)
- Applicant: Sit Sordina Iort Technologies Spa
- Decided: Jun 11, 2018 after 258 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: 4 generations back to K852907 (1985). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110840: LIAC, Sordina S.P.A. (2012) Summary page 4.
- K112286: NOVAC 11, New Radiant Technology S.P.A. (2012) Summary page 4.

## Most influential descendants
- K182374: LIAC S (2019), 0 descendants of its own

## Indications for use
LIAC HWL are mobile electron linear accelerators 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 LTAC HWL are 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. They are not for use by the general public or over-the-counter. LIAC HWL are clectron accelerators that can work in an operating theater 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/K172961
Methodology: https://510kreport.com/methodology