(34 days)
The SCT-6800TH is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TH is basically similar in design , composition and function to the SCT-7000TH(K955253). Therefore, the intended use of the SCT-6800TH is the same as that of the predicate device SCT-7000TH(K955253).
The SCT-6800TH is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning. The SCT-6800TH is basically similar in design , composition and function to the SCT-7000TH(K955253).
The provided text is a 510(k) submission document for a medical device: the Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TH. This document is a regulatory approval letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) summary typically includes a declaration of substantial equivalence to a predicate device based on similar design, composition, and function, or performance data demonstrating equivalence. However, the provided text only states that the SCT-6800TH is "basically similar in design, composition and function to the SCT-7000TH (K955253)" and that "the intended use of the SCT-6800TH is the same as that of the predicate device SCT-7000TH (K955253)."
Therefore, I cannot extract the requested information as it is not present in the provided document. The document essentially confirms that the FDA reviewed the information provided by Shimadzu Medical Systems and determined the device to be substantially equivalent to a previously marketed device (SCT-7000TH), allowing it to be marketed. Performance studies, if conducted, would have been part of the full 510(k) submission, not typically detailed in this introductory letter.
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Image /page/0/Picture/0 description: The image shows a circular seal with the logo of the U.S. Department of Health & Human Services. The seal features the department's name around the perimeter in a circular fashion. In the center is the department's symbol, which consists of a stylized caduceus-like design with three wavy lines representing the flow of life and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 8 1997
Michael Fishback Director, National Service and Regualtory Affairs Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, California 90502-1328
Re:
K973327 Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TH Dated: August 6, 1997 Received: September 4, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Fishback:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 against 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 can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 (301) 594-4613. Additionally, for question and advertising of your device, please contact 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,
hĩ liau Yi
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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510(K)Submission, SCT-6800TH
Page 1 of 1
510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________ Unknown_
Device Name: SCT-6800TH
Intended Use :
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The SCT-6800TH is an X-ray CT scanner intended for examinations of the whole body. It is equipped with a slipring , and can perform the spiral CT scanning besides conventional scanning.
The SCT-6800TH is basically similar in design , composition and function to the SCT-7000TH(K955253).
Therefore, the intended use of the SCT-6800TH is the same as that of the predicate device SCT-7000TH(K955253).
WRITE BELOW THIS LINE- CONTINUE ON PLEASE DO NOT ANOTHER PAGE IF NEEDED )
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | ||
| 510(k) Number | K913327 | |
| Prescription Use(Per21CFR801.109) | OR | Over-The-Counter Use |
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.