(36 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and does not mention any AI/ML related terms or performance metrics.
No
The device is described as an "x-ray CT Scanner w/Fluoro Option" used for "examination of the whole body," which indicates a diagnostic imaging purpose, not a therapeutic one.
Yes
Explanation: The device is an "x-ray CT Scanner w/Fluoro Option" used for the "examination of the whole body." X-ray CT scanners are imaging devices commonly used to diagnose various conditions by producing detailed images of internal body structures.
No
The device description explicitly states "SCT-7000TS x-ray CT Scanner w/Fluoro Option," indicating it is a hardware device (an x-ray CT scanner) with a software option.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "examination of the whole body" using an "x-ray CT Scanner." This describes an imaging device used to visualize internal structures of the body.
- Device Description: The device is explicitly described as an "x-ray CT Scanner."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body, which is a defining characteristic of IVDs. The input modality is "x-ray CT," not a method for analyzing biological samples.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. They typically involve the analysis of biological samples. This device is clearly an imaging device used for in-vivo examination.
N/A
Intended Use / Indications for Use
/ This device is intended to be used in the examination of the whole body. / 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
SCT-7000TS x-ray CT Scanner w/Fluoro Option
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 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 1999
Michael Fishback Director, National Service Shimadzu Medical Systems 20101 South Vermont Avenue Torrance, California 90502-1328 RE:
SCT-7000TS x-ray CT Scanner w/Fluoro Option Dated: November 12, 1998 Received: May 4, 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 referenced above 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 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 substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice 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 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
SCT-7000TS W/FLUORO OPTION Notification Submission, Page 18 510(K) INDICATION FOR USE SECTION XIII:
Page1_of1
510(K) Number(if known) : _K991553 .
SCT-7000TS W/FLUORO OPTION Device Name:
Indications For Use :
ﺔ ﻣﻦ ﺍﻟﻤﻬﺎﺟﺮ ﺍﻟﻤﻮﺍﻗﻴﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ
/ This device is intended to be used in the examination of the whole body.
/ 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-7000TS W/FLUORO OPTION is the same as that of predicate device SCT-7000TS (K980837).
Consequently, the indications for use of the SCT-7000TS W/FLUORO OPTION are also the same as that of the SCT-7000TS(K980837) and there are no additional indications.
Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, BNT, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use . (Per 21 CFR 801.109)
ﺍﺱ ﮐﮯ ﺷﮩﺮ
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