(77 days)
Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks descriptions of training/test sets or performance metrics typically associated with AI/ML devices.
No
The device is described as an X-ray CT scanner, which is a diagnostic imaging device used for scanning, not for providing therapy.
No
The description states the device is "intended to be used in X-ray CT scanning on whole body," which describes an imaging device, not a device that provides a diagnosis. Diagnostic devices interpret data to provide a medical conclusion.
No
The summary describes an X-ray CT scanning device, which is inherently a hardware-based medical device. While it might include software components, the core device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "X-ray CT scanning on whole body." This describes an imaging procedure performed on a living patient, not a test performed on a sample taken from a patient (like blood, urine, or tissue).
- Device Description: The device is an "SCT-7000TS," which is consistent with the name of a CT scanner.
- Input Imaging Modality: The input is "X-ray CT scanning," which is an in-vivo imaging technique.
- Anatomical Site: The anatomical site is "whole body," indicating imaging of a living organism.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological or pathological state. This device is used to acquire images of the human body.
N/A
Intended Use / Indications for 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.
Product codes
90 JAK
Device Description
Not Found
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
total patient population
Intended User / Care Setting
Physicians and X-ray technologist
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)
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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 (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/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
1
510(K) Number(if known) : ___Unknown
Device Name:______SCT-7000TS
Indication For Use :
6
· 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