# K063456: SRT100 Superficial Radiation Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Topex, Inc.
- Decided: Jan 9, 2007 after 55 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: 1 generation back to K962613 (1996). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 RT100: named in the summary without a submission number

## Most influential descendants
- K123985: Sensus Healthcare Superficial Radiotherapy System SRT-100 (2013), 7 descendants of its own
- 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
- K132092: Esteya (2013), 1 descendant 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. Typical applications include basal cell carcinoma, squamous cell carcinoma, Metatypic carcinoma, cutaneous appendage carcinoma and Kaposi's Sarcoma.

Source page: https://510kreport.com/device/K063456
Methodology: https://510kreport.com/methodology