# K131582: Sensus Helthcare Image-Duided Superficial Radiotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Sensus Healthcare
- Decided: Aug 28, 2013 after 89 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: 3 generations back to K962613 (1996). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123985: Sensus Healthcare Superficial Radiotherapy System SRT-100, Sensus Healthcare (2013) Summary page 1.

## Most influential descendants
- K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (2015), 3 descendants of its own
- K250692: GentleBeam (GB1000) (2025), 0 descendants of its own
- K213942: Esteya (2022), 0 descendants of its own
- K173425: SRT-100+ (2018), 0 descendants of its own

## Indications for use
The SRT-100 Vision is a low energy X-ray system, with ultrasound imaging and red-diode laser-pointing capabilities, intended for superficial radiotherapy treatment of primary malignant epithelial neoplasms of the skin and keloids. Applications include basal cell carcinoma, squamous cell carcinoma, Metatypic carcinoma, cutaneous appendage carcinoma, Kaposi's Sarcoma, and the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.

Source page: https://510kreport.com/device/K131582
Methodology: https://510kreport.com/methodology