# K112286: NOVAC 11

- Pathway: 510(k) (Traditional)
- Applicant: New Radiant Technology S.P.A.
- Decided: Apr 19, 2012 after 254 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: 3 generations back to K852907 (1985). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990209: NOVAC7, Hitesys S.P.A. (2000) Summary page 2.
- K981112: Mobetron, Intraop Medical, Inc. (1998) Summary page 2.

## Most influential descendants
- K172961: Liac HWL (2018), 1 descendant of its own
- K182374: LIAC S (2019), 0 descendants of its own

## Indications for use
The NOVAC II is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known as Intraoperative Radiation Therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues. The NOVAC II is a mobile and articulated machine that can be moved towards the patient and put in the appropriate position to carry out the necessary radiotherapy; Applicators direct the electron beam to the involved surgical area of interest.

Source page: https://510kreport.com/device/K112286
Methodology: https://510kreport.com/methodology