# K973315: Therapax DXT 300 Model HF-300

- Pathway: 510(k) (Traditional)
- Applicant: Pantak, Inc.
- Decided: Dec 2, 1997 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Therapax DXT 300 is a variable high energy X-Ray system intended for superficial to subcutaneous radiotherapy treatments of cancerous tumours and lesions. Typical applications include treatment for basal and squamous cell carcinoma, cancerous lung, breast, ribs, rectal adenocarcinoma and other intracavital sites.

Source page: https://510kreport.com/device/K973315
Methodology: https://510kreport.com/methodology