# K173425: SRT-100+

- Pathway: 510(k) (Traditional)
- Applicant: Sensus Healthcare, Inc.
- Decided: Mar 23, 2018 after 141 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: 5 generations back to K962613 (1996). 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)
- K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities, Sensus Healthcare (2015) Summary page 4.

## Indications for use
The SRT-100+ System is a low energy x-ray system, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include: (a) basal cell carcinoma; (b) squamous cell carcinoma; (c) Metatypic carcinoma; (d) cutaneous appendage carcinoma (e) Kaposi’s Sarcoma; and (f) the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue. A red-diode laser is employed for the assisting with cone applicator placement.

Source page: https://510kreport.com/device/K173425
Methodology: https://510kreport.com/methodology