← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K982265 # AQUILION CT SCANNER, MODEL TSX-101A (K982265) _Toshiba America Medical Systems, In.C · JAK · Aug 26, 1998 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K982265 ## Device Facts - **Applicant:** Toshiba America Medical Systems, In.C - **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md) - **Decision Date:** Aug 26, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. ## Device Story Aquilion (TSX-101A) is a whole-body CT scanner using slip-ring technology for continuous 360-degree rotation of X-ray tube and solid-state detector. Device acquires transmission data, which microprocessor-based computer reconstructs into 2D cross-sectional images. Supports volumetric (helical) acquisition via table movement and CT fluoroscopy. Operated by clinical staff in radiology settings. Output consists of 2D images, which may include 3D renderings, for physician review. Images assist in diagnosing head/spine injuries, tumors, blood clots, trauma, and various abdominal/musculoskeletal conditions. System utilizes standard X-ray tube and mature computer/display electronics. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing/design conformance to IEC-60601 and NEMA-PS3 (DICOM) standards. ## Technological Characteristics Whole-body CT scanner; slip-ring gantry; high-frequency X-ray controller; solid-state X-ray detector; microprocessor-based computer for image reconstruction; supports 2D and 3D rendering; DICOM compliant (NEMA-PS3); safety compliant (IEC-60601); manufactured under 21 CFR 820 Quality System Regulations. ## 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 - Toshiba TSX-011A, Xpress ([K903701](/device/K903701.md)/A) ## Related Devices - [K973908](/device/K973908.md) — AUKLET CT SCANNER, TSX-003A · Toshiba America Medical Systems, In.C · Dec 22, 1997 - [K982787](/device/K982787.md) — ASTEION CT SCANNER, TSX-021A · Toshiba America Medical Systems, In.C · Oct 21, 1998 - [K973329](/device/K973329.md) — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX · Shimadzu Medical Systems · Oct 8, 1997 - [K050458](/device/K050458.md) — TSX-201A AQUILION LB CT SCANNER · Toshiba America Medical Systems, In.C · Mar 10, 2005 - [K063189](/device/K063189.md) — TSX-301A, AQUILION ONE CT SYSTEM · Toshiba America Medical Systems, In.C · Nov 3, 2006 ## Submission Summary (Full Text) {0}------------------------------------------------ AUG 26 1998 # 510(k) Summary K982265 | Date: | 29 June 1998 | |---------------------------------------|-----------------------------------------------------------------------------------| | Submitter's Name: | Toshiba America Medical Systems, Inc. | | Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,<br>Tustin, CA 92781-2068 | | Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist, (714)730-5000 | | Establishment Registration<br>Number: | 2020563 | | Device Proprietary Name: | Aquilion CT Scanner, TSX-101A | | Common Name: | Scanner, Computed Tomography, X-Ray<br>[Fed. Reg. No. 892.1750, Pro. Code: 90JXD] | | Regulatory Class: | II (per 21 CFR 892.1750) | | Predicate Device: | Toshiba TSX-011A, Xpress [K903701/A] | | Reason For Submission | New Product | ## Description of this Device: The Aquilion (TSX-101A) is a whole body CT Scanner that employs slip ring technology which allows continuous rotation of the x-ray tube and x-ray detector. The x-ray detector collects transmission data as it and the x-ray tube rotate 360 degrees axially around a human body, Computer controlled data processing reconstructs the transmission data into a two dimensional image representing a "slice" of the body. As is common with today's CT Scanner, the Aquilion has the capability to acquire volumetric (helical) data by initiating table movement during data This data can be reconstructed per the operator's preference, to include three acquisition. dimensional rendering of the patient data. Additionally the TSX-101A is capable of CT Fluoroscopy, which is used on other Toshiba CT scanners and has received previous market clearance from the Agency. This device incorporates a standard x-ray tube and a solid state filled x-ray detector for the acquisition of data. The microprocessor based computer, hard disk storage of software and data, and display electronics are mature technologies that are standard to and well known throughout the medical device industry. ## Summary of Intended Uses: This device is designed to produce cross-sectional images of a human body by reconstruction of xray transmission data from the same axial plane taken at different angles. These image have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to examine musculoskeletal degeneration. {1}------------------------------------------------ This device employs no intended uses that are not in cleared device already found in the marketplace. ### Technological Characteristics: This device employs the same technological characteristics as the predicate device, differing only in the specifics of subassembly component composition. Both of these systems employ the use of high frequency x-ray controllers to generate x-radiation from the x-ray tube. The x-ray transmission data is detected by the x-ray detector and is reconstructed by the computer. Both of these devices produce two dimensional, black and white image that can be filmed or electronically stored for future review. #### Conformance to Standards: This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Additionally this system is in conformance with the applicable parts of the following Standards: > IEC-60601 - Medical Device Safety NEMA-PS3 - DICOM Standard {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068 Re: K982265 Aquilion CT Scanner, TSX-101A Dated: June 26, 1998 Received: June 29, 1998 Regulatory class: II 21 CFR 892,1750/Procode: 90 JAK Dear Mr. Biggins: AUG 26 1998 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 (Special Controls) or 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 (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will vertify 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 i submission does not affect any obligation you might have under sections 542 of the Act for derices 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 vitodiagnostic 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, Kiliai Yin Lillian Yin, Ph.D. 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 Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. {3}------------------------------------------------ Page __ l __ of ______________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: X-ray imaging of whole body - Computerized Tomography Including: Axial Volumetric (Helical) CT Fluoroscopy (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) -- Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Higgins --- Division Sign Off (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number A782265 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K982265](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K982265) **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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