(153 days)
This device is intended to be used in the examination of the whole body. / This device is used optionally in CT Fluoroscopy. / This device is operated and used by Physicians and X-ray technologist. / The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7000TX W/FLUORO OPTION is the same as that of predicate device SCT-7000TX (K955255) except optional CT fluoroscopy . Consequently, the indications for use of the SCT-7000TX W/FLUORO OPTION are also the same as that of the SCT-7000TX (K955255) except optional CT fluoroscopy
SCT-7000TX X-ray CT Scanner with Fluoro Option
The provided documents are correspondence from the FDA regarding a 510(k) clearance for the Shimadzu SCT-7000TX X-ray CT Scanner with Fluoro Option (K984156), and an "Indications For Use" statement.
These documents do not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. They are administrative documents related to regulatory clearance based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three abstract shapes forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 1999
Michael Fishback Director. National Service and Regulatory Affairs Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, California 90502-1328
Re:
K984156 SCT-7000TX X-ray CT Scanner with Fluoro Option Dated: February 1, 1999 Received: February 10, 1999 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 legally marketed predicate 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 dass 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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 (301) 594-4613. Additionally, for questions on the promotion 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/dsma/dsmamain.html".
Sincerely yours,
Dan Setiz
CAPT Daniel G. Schultz, M.D. Acting 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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Appendix B
Notification Submission, SCT-7000TX W/FLUORO OPTION Page 18A 510(K)
INDICATION FOR USE SECTION XIII:
Page1 of1
510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________
SCT-7000TX W/FLUORO OPTION Device Name:
Indications For Use :
/ This device is intended to be used in the examination of the whole body.
/ This device is used optionally in CT Fluoroscopy.
/ This device is operated and used by Physicians and X-ray technologist.
/ The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7000TX W/FLUORO OPTION is the same as that of predicate device SCT-7000TX (K955255) except optional CT fluoroscopy .
Consequently, the indications for use of the SCT-7000TX W/FLUORO OPTION are also the same as that of the SCT-7000TX (K955255) except optional CT fluoroscopy
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use (Per21CFR801.109) OR
Over-The-Counter Use
David L. Lynn
Division Sign-Off ivision of Reproductive, Abdominal, EN and Radiological I
§ 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.