← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K991553 # SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION (K991553) _Shimadzu Corp. · JAK · Jun 8, 1999 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K991553 ## Device Facts - **Applicant:** Shimadzu Corp. - **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md) - **Decision Date:** Jun 8, 1999 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Intended 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. ## Device Story SCT-7000TS w/Fluoro Option is an X-ray CT scanner designed for whole-body imaging. Operated by physicians and X-ray technologists in clinical settings, the device acquires X-ray projection data to reconstruct cross-sectional images of the patient. The 'Fluoro Option' provides additional imaging capabilities consistent with the predicate device. Output images are reviewed by healthcare professionals to assist in diagnostic decision-making. The device benefits patients by providing non-invasive anatomical visualization for clinical assessment. ## Clinical Evidence Bench testing only. ## Technological Characteristics X-ray CT scanner system. Operates via X-ray projection acquisition and image reconstruction. System is intended for whole-body diagnostic imaging. Connectivity and software details are consistent with the predicate SCT-7000TS. ## Regulatory 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. ## Predicate Devices - SCT-7000TS ([K980837](/device/K980837.md)) ## Related Devices - [K984156](/device/K984156.md) — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION · Shimadzu Medical Systems · Apr 21, 1999 - [K980837](/device/K980837.md) — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS · Shimadzu Medical Systems · May 20, 1998 - [K994431](/device/K994431.md) — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES · Shimadzu Medical Systems · Mar 23, 2000 - [K982583](/device/K982583.md) — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL · Shimadzu Corp. · Oct 5, 1998 - [K973327](/device/K973327.md) — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH · Shimadzu Medical Systems · Oct 8, 1997 ## Submission Summary (Full Text) {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: K991553 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 ﺳﯿﻨﭧ . --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K991553](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K991553) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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