SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS

K980837 · Shimadzu Medical Systems · JAK · May 20, 1998 · Radiology

Device Facts

• Record ID: K980837
• Device Name: SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
• Applicant: Shimadzu Medical Systems
• Product Code: JAK · Radiology
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

This device is intended to be used in X-ray CT scanning on whole body. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient population.

Device Story

SCT-7000TS is a whole-body X-ray computed tomography (CT) scanner. Device acquires X-ray projection data to generate cross-sectional images of patient anatomy. Operated by physicians and X-ray technologists in clinical settings. Output consists of diagnostic CT images used by clinicians to visualize internal structures, aid in diagnosis, and inform clinical decision-making. Device functions as a standard radiological imaging system.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Whole-body X-ray CT scanner. Operates via X-ray radiation source and detector array to produce tomographic images. Class II device (21 CFR 892.1750).

Indications for Use

Indicated for whole body X-ray CT scanning for the total patient population. Operated by physicians and X-ray technologists.

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-7000TX (K955255)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 0 1998

Michael Fishback Director, National Service and Regulatory Affairs Shimadzu Corporation 20101 South Vermont Avenue Torrance, CA 90502-1328

Re: K980837 Shimadzu Whole Body x-ray Computed Tomography Scanner SCT-7000TS Dated: February 16, 1998 Received: March 4, 1998 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 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 (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 (OS) for Medical Devices: General regulation (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 predication 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 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/dsmaldsmamain.html".

Sincerely yours,
Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K980837

510(K) Number(if known) : ___Unknown

Device Name:______SCT-7000TS

Indication For Use :

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· This device is intended to be used in X-ray CT scanning on whole body.

· This device is operated and used by Physicians and X-ray technologist.

· The object of this device is total patient population.

As mentioned at " Intended Use " in this clearance letter, the intended use of the SCT-7000TS is as same as that of predicate device SCT- 7000TX ( K955255) and there is no additional indication.

(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 C. Stymon

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