(204 days)
To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.
CS2000 & CS2000 Tomo (Radiographic table with integrated X-ray tube stand and tomograph
The provided document is a 510(k) premarket notification letter from the FDA for a radiographic table with an integrated X-ray tube stand and tomograph (CS2000 & CS2000 Tomo). This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way described in your request.
The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed results as you've outlined.
Therefore, I cannot extract the requested information (1-9) from this document. The letter primarily confirms that the device is substantially equivalent for its stated indications for use: "To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician."
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image. The words are arranged in a single line.
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 1998
Kenneth J.H. Tice Official Correspondent Pausch Corporation 808 Shrewsbury Avenue Tinton Falls, NJ 07724-3002 Re:
CS2000 & CS2000 Tomo (Radiographic table with integrated X-ray tube stand and tomograph Dated: March 27, 1998 Received: March 30, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 IZF
Dear Mr. Tice:
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 (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. 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/cdrb/dsmaldsmam.html".
Sincerely yours,
Kilian Yin
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
{1}------------------------------------------------
808 SHREWSBURY AVENUE, TINTON FALLS, NJ 07724-3002
INDICATION FOR USE STATEMENT
510(k) Number K973834
Device Name: CS2000 and CS2000 TOMO
:
Indications For Use:
To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| Prescription Use | OR | 510(k) Number: K973834/sa |
|---|---|---|
| (Per 21 CFR 801.109) | ||
| Prescription Use | ||
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Image /page/1/Picture/12 description: The image shows the word "PAUSCH" in a bold, sans-serif font. The letter "A" is stylized with a diagonal line extending from the top left to the bottom right, creating a unique visual element. The letters are closely spaced, forming a compact and unified wordmark.
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.