THERAPAX SXT 150

K971074 · Pantak, Inc. · JAD · Jun 13, 1997 · Radiology

Device Facts

• Record ID: K971074
• Device Name: THERAPAX SXT 150
• Applicant: Pantak, Inc.
• Product Code: JAD · Radiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Therapax SXT 150 is a variable low energy x-ray system intended for superficial radiotherapy treatments of cancerous tumors and lesions. Typical applications include treatment for basal cell carcinoma, squamous cell carcinoma, Karposi’s Sarcoma, rectal adenocarcinoma and other intracavital sites.

Device Story

Therapax SXT 150 is a variable low-energy X-ray system for superficial radiotherapy. Device delivers ionizing radiation to treat cancerous tumors and lesions, including basal cell carcinoma, squamous cell carcinoma, Karposi’s Sarcoma, and rectal adenocarcinoma. Operated by clinical professionals in a radiotherapy setting. System provides localized radiation therapy to target sites, including intracavital applications. Output is controlled radiation dose, enabling treatment of superficial malignancies. Benefits include precise delivery of therapeutic radiation to localized disease sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Variable low-energy X-ray therapy system. Designed for superficial and intracavital radiotherapy. Operates as a standalone medical X-ray unit.

Indications for Use

Indicated for superficial radiotherapy treatment of cancerous tumors and lesions, including basal cell carcinoma, squamous cell carcinoma, Karposi’s Sarcoma, and rectal adenocarcinoma in patients requiring localized radiation therapy.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Greg Moreau
Pantak, Inc.
31 Business Park Drive
P.O. Box 865
Branford, CT 06405
JUN 13 1997

Re: K971074
Therapax SXT 150 X-Ray Therapy Device
Dated: March 14, 1997
Received: March 24, 1997
Regulatory class: II
21 CFR 892.5900/Procode: 90 JAD

Dear Mr. Moreau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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Section 3: Indications for Use

The Therapax SXT 150 is a variable low energy x-ray system intended for superficial radiotherapy treatments of cancerous tumors and lesions. Typical applications include treatment for basal cell carcinoma, squamous cell carcinoma, Karposi’s Sarcoma, rectal adenocarcinoma and other intracavital sites.

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971074

Prescription Use ☑
(Per 21 CFR 801.109)

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