(14 days)
Acquisition and display of axial x-ray images of the whole body to include the head.
The TSX-301A/1 is a whole body CT scanner. This device produces axial images that may be reconstructed into 3-D volumes. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
This 510(k) premarket notification for the TSX-301A, Aquilion ONE CT System from Toshiba America Medical Systems, Inc. does not contain information regarding
acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document focuses on:
- Device description: A whole-body CT scanner that produces axial images reconstructable into 3D volumes.
- Intended Uses: To produce cross-sectional data sets of the anatomy.
- Technological Characteristics: Similar materials and processes to its predicate device, the Toshiba TSX-101A/H Aquilion 64 SP CT scanner.
- Safety and Effectiveness Concerns: Designed and manufactured under Quality System Regulations (21 CFR § 820.30) and Federal Diagnostic Equipment standards (21 CFR § 1020.30 and 1020.33). Conforms to applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-44.
- Substantial Equivalence: Claimed to be substantially equivalent to the Toshiba TSX-101A/H Aquilion 64 SP CT scanner.
- FDA Clearance: The FDA found the device substantially equivalent to a legally marketed predicate device on November 3, 2006.
- Indications for Use: Acquisition and display of axial x-ray images of the whole body, including the head.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text.
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Ko 6 3189
Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification
510(k) Summary
| Date: | September 28, 2006 | NOV - 3 2006 |
|---|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. | |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, | |
| Submitter's Contact:(714)730-5000 | Paul Biggins, Regulatory Affairs Specialist, | |
| Tustin, CA 92781-2068 | ||
| Establishment RegistrationNumber: | 2020563 | |
| Device Proprietary Name: | TSX-301A, Aquilion ONE CT System | |
| Common Name: | Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code: 90JAK] | |
| Regulatory Class: | II (per 21 CFR 892.1750) | |
| Performance Standard: | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard | |
| Predicate Device(s): | TSX-101A/I Aquilion 64 SP CT System | |
| Reason For Submission | New device |
Description of this Device:
The TSX-301A/1 is a whole body CT scanner. This device produces axial images that may be reconstructed into 3-D volumes. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display.
Summary of Intended Uses:
This device is intended to produce cross sectional data sets of the anatomy.
Technological Characteristics:
This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate cross sectional images of the anatomy.
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Toshiba America Medical Systems, Inc. 510(k) Pre-market Notification
Safety and Effectiveness Concerns:
Salety and Effectiveness Concerns.
This device is designed and manufactured under the Quality System Regulations as This device is designed and managuirements of the Federal Diagnostic Equipment outmed in 21 CFR § 020.30 and 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate with be the reported vithis system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-44. -Medical Device Safety standards .
Substantial Equivalence:
This device is similar in materials and processes to that of the predicate device, Toshiba TSX-101A/H Aquilion 64 SP CT scanner.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Toshiba America Medical Systems, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, N.W. BUFFALO MN 55313
Re: K063189
Trade/Device Name: TSX-301A, Aquilion ONE CT System Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 16, 2006 Received: October 20, 2006
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
NOV - 3 2006
If your device is classified (see above) into cither 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/9 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial".
I Promoting Public 9
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 (81 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely vours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO63189 510(k) Number (if known):
TSX-301A, Aquilion ONE CT System Device Name:
Indications For Use:
Acquisition and display of axial x-ray images of the whole body to include the head.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Varnest Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063189
،
§ 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.