# K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

- Pathway: 510(k) (Traditional)
- Applicant: Sensus Healthcare
- Decided: Oct 16, 2015 after 280 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962613 (1996). 5 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K131582: Sensus Helthcare Image-Duided Superficial Radiotherapy System, Sensus Healthcare (2013) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Feb 10, 2023 · Class II · Z-1235-2023: When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.

## Indications for use
The SRT-100 Vision System is a low energy x-ray system, with ultrasound imaging capability, intended for superficial radiotherapy and electronic brachytherapy 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 (¢) 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. The ultrasound capability, employed in a non-diagnostic mode, is used to assist the physician in the selection of the correct cone applicator size. The Derma-Scan C Ultrasound component was initially cleared with an indication for use as an ultrasonic scanning system used to visualize the layers of skin, including bold vessels, and to make approximate measurements of dimensions in layers of skin and blood vessels, by ultrasonic means. The red-diode laser assembly is a commercial pointer device employed by physicians for improving the alignment of the focused beam.

Source page: https://510kreport.com/device/K150037
Methodology: https://510kreport.com/methodology