CS2000 & CS2000 TOMO

K973834 · Pausch Corp. · IZF · Apr 30, 1998 · Radiology

Device Facts

• Record ID: K973834
• Device Name: CS2000 & CS2000 TOMO
• Applicant: Pausch Corp.
• Product Code: IZF · Radiology
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1740
• Device Class: Class 2

Intended Use

To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.

Device Story

The CS2000 and CS2000 TOMO are radiographic tables with integrated X-ray tube stands and tomographic capabilities. The device is used in clinical settings by trained radiologic technologists or physicians to perform diagnostic imaging. It supports standard radiographic procedures and tomographic imaging, providing images that assist clinicians in diagnosing patient conditions. The system functions as a mechanical and radiological platform for positioning patients and aligning X-ray sources for image acquisition.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radiographic table with integrated X-ray tube stand and tomographic functionality. Class II device under 21 CFR 892.1750 (Procode: 90 IZF).

Indications for Use

Indicated for patients requiring radiography and radiographic tomography examinations as prescribed by a licensed physician.

Regulatory Classification

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.

Submission Summary (Full Text)

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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:

K973834

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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 | <div style="text-align:left;">OR</div> | 510(k) Number: K973834/sa |
|----------------------|----------------------------------------|---------------------------|
| (Per 21 CFR 801.109) | | |
| | Prescription Use | |
| | (Per 21 CFR 801.109) | (Optional Format 1-2-96) |

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