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K Number
K973315
Device Name
THERAPAX DXT 300 MODEL HF-300
Manufacturer
PANTAK, INC.
Date Cleared
1997-12-02

(90 days)

Product Code
JAD
Regulation Number
892.5900
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

Therapax DXT 300 X-Ray Therapy Device - Model HF-300

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for an X-ray therapy device, the Therapax DXT 300. It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance using the requested metrics.

Therefore, I cannot provide the requested information from this document. The document primarily states that the device is substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

Here's why the requested information is absent:

  • Acceptance Criteria & Performance Table: This type of detail is typically found in a clinical study report or a technical performance validation document, not a 510(k) clearance letter. The letter confirms regulatory equivalence, not specific performance metrics.
  • Sample Size & Data Provenance: Not mentioned.
  • Number & Qualifications of Experts for Ground Truth: Not mentioned.
  • Adjudication Method: Not mentioned.
  • MRMC Comparative Effectiveness Study: Not mentioned as this is a therapy device, not an AI diagnostic tool where MRMC studies are common.
  • Standalone Performance Study: Not mentioned.
  • Type of Ground Truth: Not mentioned.
  • Training Set Sample Size: Not applicable as this is not an AI/ML device.
  • Ground Truth for Training Set: Not applicable.

§ 892.5900 X-ray radiation therapy system.

(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.