# K182641: Sensus IORT System

- Pathway: 510(k) (Traditional)
- Applicant: Sensus Healthcare, Inc.
- Decided: Feb 21, 2019 after 150 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K864210 (1986). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153570: Axxent Electronic Brachytherapy System Model 110 XP 1200, Icad, Inc. (2016) Summary page 4.

## Indications for use
The Sensus IORT System is indicated for radiation therapy treatments. The Sensus IORT System is an electron linear accelerator with a beam-forming x-ray target used for low energy radiation therapy to treat lesions, tumors, and conditions in or on the body where radiation is indicated. Only Sensus TVM Balloon Applicators can be used with the Sensus IORT System.

Source page: https://510kreport.com/device/K182641
Methodology: https://510kreport.com/methodology