(84 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention any AI/ML related terms in the intended use or device description.
No.
The device is used for examination (diagnosis) and imaging, not for treating any condition.
Yes
Explanation: The device is described as a "Whole Body X-ray Computed Tomography Scanner," which is a type of imaging device used to examine the body for diagnostic purposes. Its intended use for "examination of the whole body" implies it's used to identify medical conditions, which falls under diagnostic activity.
No
The device description explicitly states "Shimadzu Whole Body X-ray Computed Tomography Scanner SCT-7800 Series", indicating it is a hardware device (a CT scanner) with associated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) in vitro (outside the body).
- This device is an X-ray Computed Tomography Scanner. It directly examines the human body in vivo (inside the body) using X-rays.
- The intended use and device description clearly state it's for examining the "whole body" and is operated by physicians and X-ray technologists. This aligns with imaging devices used for diagnosis based on internal structures, not laboratory analysis of specimens.
N/A
Intended Use / Indications for Use
/ This device is intended to be used in the examination of the whole body. / This device is used optionally in CT Fluoroscopy. / This device is operated and used by Physicians and X-ray technologist. / The object of this device is total patient populations.
Product codes
90 JAK
Device Description
Shimadzu Whole Body X-ray Computed Tomography Scanner SCT-7800 Series ( 3 models, minor variations)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
whole body
Indicated Patient Age Range
total patient populations
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/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three wing-like shapes, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2000
Michael Fishback Director, National Service and Regulatory Affairs Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, CA 90502-1328
Re: K994431
Shimadzu Whole Body X-ray Computed Tomography Scanner SCT-7800 Series ( 3 models, minor variations) Dated: December 15, 1999 Received: December 30, 1999 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 and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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 substantially equivalion assumes compliance with the Current Good Manufacturing Pracice requirements, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning vour 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) 594-4591. 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" (21CFR 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel C. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
1
Page1 of1
510(K) Number(if known) : ____________________________________________________________________________________________________________________________________________________ Hokoovin
SCT-7800T series Device Name:
Indications For Use :
/ This device is intended to be used in the examination of the whole body.
/ This device is used optionally in CT Fluoroscopy.
/ This device is operated and used by Physicians and X-ray technologist.
/ The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7800T series is the same as that of predicate device SCT-7000TS W/FLUORO OPTION (K991553).
Consequently, the indications for use of the SCT-7800T series are also the same as that of the SCT-7000TS W/FLUORO OPTION (K991553) and there are no additional indications.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation(ODE)
OR
Prescription Use (Per21CFR801.109)
Over-Th
Over-The-Counter Use
Harind the beymann
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number