(81 days)
The Therapax SXT 150 is a variable low energy x-ray system intended for superficial cases and lesions. Typical applications include radiotherapy treatments of cancerous tumors and research. Typical treatments include treatment for basal cell carcinoma, squamous cell carcinoma, Karpos's Sarcoma, rectal adenocarcinoma and other intracavital sites.
variable low energy x-ray system
This is a letter acknowledging the receipt and review of a 510(k) premarket notification for the "Therapax SXT 150 X-Ray Therapy Device." This document itself does not contain any information about acceptance criteria or a study proving device performance against such criteria. It is a regulatory approval letter based on the device being substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from the given text.
To address your request, I would need a different document, such as a 510(k) summary, a clinical study report, or a technical specification document that describes the device's performance characteristics and the studies conducted to establish them.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Greg Moreau Pantak, Inc. 31 Business Park Drive P.O. Box 865 JUN 1 3 1997 Branford, CT 06405
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: 会
We have reviewed your Secuon 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 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 and prohibitions gainst misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device and in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substanially 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 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 southeation. The FDA finding of . substantial equivalence of your device to a legally marketed predication 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 (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please ontact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Section 3:
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The Therapax SXT 150 is a variable low energy x-ray system intended for superficial The Therapax SX1 150 is a variable tow cases and lesions. Typical applications include radiotherapy treatments of cancerous tumous and resears. " years of "
treatment for basal cell carcinoma, squamous cell carcinoma, Karposi's Sarcoma, rectal adenocarcinoma and other intracavital sites.
David A. Kepner
(Division Sign-Off)
(Person of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .
Prescription Use _ (Per 21 CFR 801.109)
§ 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.