# K123985: Sensus Healthcare Superficial Radiotherapy System SRT-100

- Pathway: 510(k) (Traditional)
- Applicant: Sensus Healthcare
- Decided: May 14, 2013 after 139 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: 2 generations back to K962613 (1996). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063456: SRT100 Superficial Radiation Therapy System, Topex, Inc. (2007)
- K971074: Therapax SXT 150, Pantak, Inc. (1997) Summary page 1.
- K962613: Darpac 2000 Superficial X-Ray Therapy System, Gulmay Medical, Ltd. (1996) Summary page 1.
- (no number) Philips RT 100: named in the summary without a submission number

## Most influential descendants
- K131582: Sensus Helthcare Image-Duided Superficial Radiotherapy System (2013), 4 descendants of its own
- K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (2015), 3 descendants of its own
- K172080: Photoelectric Therapy System (2017), 1 descendant of its own
- K250692: GentleBeam (GB1000) (2025), 0 descendants of its own
- K230611: X80 / RADiant / PhotoElectric Therapy System  (RADiant Aura) (2023), 0 descendants of its own

## Indications for use
The SRT-100 is a low energy X-ray system 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, Karposi'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/K123985
Methodology: https://510kreport.com/methodology