IMAX CEPH DIGITAL X-RAY SENSOR

K062403 · Owandy · MUH · Nov 14, 2006 · Dental

Device Facts

• Record ID: K062403
• Device Name: IMAX CEPH DIGITAL X-RAY SENSOR
• Applicant: Owandy
• Product Code: MUH · Dental
• Decision Date: Nov 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The IMAX CEPH digital X-ray sensor is intended to capture extra oral x-ray images of a patient's head when exposcd to X-rays for diagnostic purposes. The process is automatic and continues transmitting the digital image to a Personal Computer VIA USB interface.

Device Story

The Imax CEPH Digital X-ray Sensor captures extraoral X-ray images of a patient's head for diagnostic purposes. The device functions by detecting X-ray exposure and automatically transmitting the resulting digital image to a connected personal computer via a USB interface. It is intended for use in clinical settings by healthcare professionals. The output is displayed on a computer screen, allowing the clinician to review the diagnostic images to assist in clinical decision-making and patient assessment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Digital X-ray sensor; USB interface for data transmission to PC; extraoral imaging system; 21 CFR 892.1800.

Indications for Use

Indicated for capturing extraoral X-ray images of a patient's head for diagnostic purposes.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle head with three lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 6 2007

Owandy % Mr. Claude D. Berthoin President Video Dental Concepts, Inc. 110E. Granada Boulevard, Suite 207 ORMOND BEACH FL 32175

Re: K062403

Trade/Device Name: Imax CEPH Digital X-ray Sensor Regulation Number: 21 CFR 892.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 13, 2006 Received: October 16, 2006

Dear Mr. Berthoin:

This letter corrects our substantially equivalent letter of November 14, 2006.

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 (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 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

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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 continue marketing your device as described in your Section 510(k) I mis letter will and my Jorne FDA finding of substantial equivalence of your device to a legally premater nouncearent ' - e 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 in you atence 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 from the Division of Small other general informational 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

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## INDICATION FOR USE

OWANDY Applicant: .

510(k) Number (if known): K062403

IMAX CEPH DIGITAL X-RAY SENSOR Device Name:

The IMAX CEPH digital X-ray sensor is intended Indication of use: to capture extra oral x-ray images of a patient's head when exposcd to X-rays for diagnostic purposes.

The process is automatic and continues transmitting the digital image to a Personal Computer VIA USB interface.

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Concurrence of CDRH, Office of Device Evaluation(ODE)

*Prescription Use*

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Devices 510(k) Number