K Number
K973329
Device Name
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
Date Cleared
1997-10-08

(34 days)

Product Code
Regulation Number
892.1750
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SCT-6800TX 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-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ) . Therefore, the intended use of the SCT-6800TX is the same as that of the predicate device SCT-7000TX(K955255).
Device Description
The SCT-6800TX 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-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ) .
More Information

No
The summary describes a standard CT scanner and makes no mention of AI, ML, or advanced image processing techniques typically associated with these technologies.

No
The device is described as an X-ray CT scanner intended for "examinations of the whole body," which indicates a diagnostic rather than a therapeutic purpose.

Yes
The device is described as an "X-ray CT scanner intended for examinations of the whole body," which is a diagnostic imaging procedure.

No

The device description explicitly states it is an "X-ray CT scanner," which is a hardware device.

Based on the provided information, the SCT-6800TX is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states it's an "X-ray CT scanner intended for examinations of the whole body." This describes an imaging device used to visualize internal structures of the body, not a device used to examine specimens taken from the body (like blood, urine, or tissue).
  • Device Description: The description reinforces that it's an "X-ray CT scanner" and mentions "examinations of the whole body," further indicating it's an in-vivo imaging device.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens.
    • Detecting or measuring substances in specimens.
    • Providing information for diagnosis based on laboratory tests.

IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. X-ray CT scanners are used to create images of the body.

N/A

Intended Use / Indications for Use

The SCT-6800TX 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-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ).

Therefore, the intended use of the SCT-6800TX is the same as that of the predicate device SCT-7000TX(K955255).

Product codes

90 JAK

Device Description

The SCT-6800TX 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-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray CT

Anatomical Site

whole body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K955255

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is an abstract image of a person with their arms outstretched. The image is black and white.

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:

K973329 Shimadzu Whole Body X-Ray Computed Tomography Scanner SCT-6800TX 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 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 requirement, as set forth in the Quality System Regulation (QS) 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 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.

H.Liau Yu

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

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510(K)Submission, SCI-6800TX

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510(K) Number(if known) : ___________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Intended Use :

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新闻

The SCT-6800TX 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-6800TX is basically similar in design , composition and function to the SCT-7000TX ( K955255 ) .

Therefore, the intended use of the SCT-6800TX is the same as that of the predicate device SCT-7000TX(K955255).

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON 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) NumberK973329
------------------------
Prescription UseOROver-The-Counter Use
(Per21CFR801.109)