CDR PANX, MODEL 4792

K031291 · Schick Technologies, Inc. · MUH · May 5, 2003 · Dental

Device Facts

• Record ID: K031291
• Device Name: CDR PANX, MODEL 4792
• Applicant: Schick Technologies, Inc.
• Product Code: MUH · Dental
• Decision Date: May 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

Device Story

CDR PanX Model 4792 is a digital panoramic X-ray system. High-voltage power supply energizes an X-ray tube to emit pulses attenuated by the patient's head. A digital receptor captures the resulting image data, which is transmitted to a computer for processing and display on a monitor. The X-ray source and receptor revolve on a motion stage to generate multiple projections, creating a panoramic view of the skull. Used in dental clinical settings by trained operators to assist in diagnostic imaging of the maxillofacial region.

Clinical Evidence

Bench testing only. Radiation survey confirmed patient exposure levels are similar to the predicate device. Device conforms to electrical safety standards and 21 CFR 1020.30-31.

Technological Characteristics

Digital panoramic X-ray system; high-voltage power supply; X-ray tube source; digital receptor; motion stage for rotational projection; computer-based image processing and display. Complies with 21 CFR 1020.30-31.

Indications for Use

Indicated for individuals requiring extra-oral dental exams of the dento-maxillofacial region.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Soredex Cranex Tome system

Reference Devices

• CDR PAN MODEL 4700 (K982661)

Submission Summary (Full Text)

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# Ko3 1291

MAY - 5 2003

## Exhibit IV: 510(k) Summary

# Schick CDR PANX MODEL 4792

Common/Classification Name: "DIGITAL X-RAY EXTRAORAL SOURCE! SYSTEM" 21CFR872.1800

> Schick Technologies, Inc. 30-00 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: April 10, 2003

#### A. Legally Marketed Predicate Devices

The Soredex Cranex Tome system is a legally marketed predicate device that emits x-ray radiation for panoramic radiographs. By default, the Soredex system utilizes x-ray film, however a digital receptor that subsequently received clearance under K982661, may also be used with the device. Schick Technologies has now demonstrated equivalence of a new integrated digital panoramic machine to the Soredex system.

#### B. Device Description

The CDR PanX Model 4792 is a digital panoramic device. A high voltage power supply charges an x-ray tube that emits a pulse which is attenuated by the patient's head. An FDA approved digital receptor receives the resultant image and transmits the data to a computer. The receptor and x-ray source both revolve on a motion stage such that multiple projections may be generated thereby resulting in a panoramic view of the skull. The computer processes and displays the image data on a monitor.

#### C. Indications for Use

The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

#### D. Substantial Equivalence Summary

The CDR PanX Model 4792 is substantially equivalent to digital panoramic units currently marketed in the U.S. The Soredex Cranex Tome is similar in that it is

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indicated for, among other things, panoramic x-ray examinations of the maxillofacial region, although it traditionally utilizes film. It can, however, be retrofit with the CDR – PAN MODEL 4700, which is the same sensor as is utilized in this new integrated product.

### E. Testing

A radiation survey has confirmed that the device exposes the patient to similar radiation as the predicate. In addition, the device conforms with electrical safety standards and 21CFR 1020.30-31.

### F. Conclusions

Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2003

Schick Technologies % Mr. Donald J. Sherratt Medical Stream Director Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719 Re: K031291

Trade/Device Name: CDR PanX Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II

Product Code: 76 MUH

Dated: April 22, 2003 Received: April 23, 2003

Dear Mr. Sherratt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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.

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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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon.

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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of I Page 1

1163 1291 510(k) Number (if known):_

Device Name:_CDR PanX

Indications For Use:

The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

*Prescription Use* ✓

Daniel R. Seymm

Sign-Off I Reproductive mner