COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO

K973864 · Pausch Corp. · IZF · Jun 17, 1998 · Radiology

Device Facts

• Record ID: K973864
• Device Name: COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO
• Applicant: Pausch Corp.
• Product Code: IZF · Radiology
• Decision Date: Jun 17, 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 Combi Elevator-2 and Combi Elevator-2 Microtom are radiographic systems used in clinical settings for diagnostic imaging. The devices facilitate radiography and radiographic tomography examinations. Operated by trained radiology personnel under the direction of a licensed physician, the systems assist in capturing internal anatomical images. These images are utilized by clinicians to support diagnostic decision-making and patient care. The devices function as standard radiographic equipment for general imaging purposes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radiographic and tomographic imaging system. Class II device under 21 CFR 892.1740, 892.1770, and 892.1980. Technical specifications and materials are consistent with standard radiographic equipment.

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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1998

Kenneth J. H. Tice Vice President Official Correspondent Pausch Corporation 808 Shrewsbury Avenue Tinton Falls, NJ 07724-3002 Re:

Combi Elevator-2 & Combi Elevator- 2 Microtom Dated: March 27, 1997 Received: May 14, 1997 Regulatory class: II 21 CFR 892.1740/Procode: 90 IZF 21 CFR 892.1770/Procode: 90 IYB 21 CFR 892.1980/Procode: 90 IZZ

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.

K973864

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 (OS) 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 yitto disgnostic 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/cdri/dsmaldsmamain.html",

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Sincerely yours,

William Yh

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TEL: [phone] FAX: [phone]

## INDICATION FOR USE STATEMENT

510(k) Number K973864

Device Name: Combi Elevator-2 and Combi Elevator-2 Microtom

Indications For Use:

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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)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973864
510k Combi Elevator-2 Indications for use statement Page 1 of 1

PAUSCH