SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH

K973327 · Shimadzu Medical Systems · JAK · Oct 8, 1997 · Radiology

Device Facts

• Record ID: K973327
• Device Name: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
• Applicant: Shimadzu Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

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.

Device Story

SCT-6800TH is a whole-body X-ray computed tomography (CT) scanner; utilizes slip-ring technology to enable both conventional and spiral (helical) scanning modes. Operated by trained radiology personnel in clinical settings; acquires X-ray attenuation data to reconstruct cross-sectional images of patient anatomy. Output images are reviewed by radiologists to assist in diagnostic decision-making. Device design and function are substantially equivalent to the predicate SCT-7000TH.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and functional similarity to the predicate device.

Technological Characteristics

Whole-body X-ray CT scanner; features slip-ring gantry design; supports conventional and spiral scanning modes. Class II device (21 CFR 892.1750).

Indications for Use

Indicated for whole body X-ray computed tomography examinations in patients requiring diagnostic imaging.

Regulatory Classification

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.

Predicate Devices

• SCT-7000TH (K955253)

Submission Summary (Full Text)

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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 [phone]. Additionally, for question 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,

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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感

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).

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| Concurrence of CDRH, Office of Device Evaluation(ODE) | | |
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| <div><img alt="signature" src="signature.png"/></div> | | |
| (Division Sign-Off) | | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | | |
| 510(k) Number | K913327 | |
| Prescription Use<br>(Per21CFR801.109) | OR | Over-The-Counter Use |