(73 days)
No
The summary does not mention AI, ML, or any related terms, and the device description is not provided.
No
The device is described as being used for X-ray CT scanning, which is a diagnostic imaging technique, not a therapeutic intervention. Its intended use is to acquire images for diagnosis, not to treat a disease or condition.
Yes
Explanation: The device is an X-ray CT scanner, which is used to generate images of the body to aid in the diagnosis of various medical conditions. The "Intended Use" explicitly states "X-ray CT scanning on whole body," which is a diagnostic imaging modality.
No
The summary describes a device used in X-ray CT scanning, which is a hardware-based imaging modality. While the summary lacks a detailed device description, the context of CT scanning strongly implies a hardware component. There is no mention of the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "X-ray CT scanning on whole body." This describes an imaging device used on the patient, not a device used to test samples from the patient (which is the definition of an in vitro diagnostic).
- 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 it's used on the patient's body.
- Intended User: The intended users are "Physicians and X-ray technologist," who operate imaging equipment.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device is used to create images of the inside of the body directly.
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.
- As mentioned at " Intended Use " in this clearance letter, the intended use of the SCT-6800TXL is as same as that of predicate device SCT- 7000TX ( K955255) and there is no additional indication.
Product codes
90 JAK
Device Description
X-ray CT Scanner SCT-6800TXL
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 logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name in a ring around the outside. Inside the ring is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1998
Michael Fishback Director, National Service and Regulatory Affairs Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, CA 90502-1328
Re:
K982583 X-ray CT Scanner SCT-6800TXL Dated: July 23, 1998 Received: July 24, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Fishback:
We have reviewed your Section 510%) 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 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 substantiation 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 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 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/odrh/dsmaldsmamain.html".
Sincerely yours,
William Yi
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
Page 1_of_1_
ાં (૧)
48,2583 510(K) Number(if known) : ___Unknown-
Device Name: SCT-6800TXL
Indication 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.
As mentioned at " Intended Use " in this clearance letter, the intended use of the SCT-6800TXL 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 V (Per21CFR801.109)
1 141 11
OR
Over-The-Counter Use
Wind C. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982583