IMAGERAYI

K041580 · Henry Schein, Inc. · MUH · Jun 29, 2004 · Dental

Device Facts

• Record ID: K041580
• Device Name: IMAGERAYI
• Applicant: Henry Schein, Inc.
• Product Code: MUH · Dental
• Decision Date: Jun 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The digital x-ray sensor system, ImageRAYi, of Dental Systems, Inc. which is a subsidiary of Henry Schein Company, Inc., and its related components are used to provide instant x-ray is a suosimar of Homan oral tissue (dentin). The digital x-ray sensor system, ImageRAYi, replaces standard intraoral x-ray film and uses the same x-ray source.

Device Story

ImageRAYi is a digital x-ray sensor system designed for dental imaging. It captures x-ray radiation transmitted through oral tissue (dentin) using a digital sensor, replacing traditional intraoral x-ray film. The system utilizes the same x-ray source as conventional film-based systems. It is intended for use by dental professionals in clinical settings to provide instant visualization of dental structures. The output is a digital image displayed for the clinician, facilitating diagnostic assessment of oral health. The device benefits patients by providing immediate imaging results, reducing the need for film processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital x-ray sensor system; intraoral form factor; utilizes existing dental x-ray sources; replaces film-based imaging; digital signal acquisition.

Indications for Use

Indicated for dental patients requiring intraoral x-ray imaging of oral tissue (dentin). Replaces standard intraoral x-ray film using existing x-ray sources.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2004

Dentrix Dental Systems, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313

Re: K041580 Trade/Device Name: ImageRAYi Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: June 10, 2004 Received: June 14, 2004

Dear Mr. Job:

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 such 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 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. Brygdon

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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## PRE-MARKET NOTIFICATION

INDICATIONS FOR USE

510(k) Number: Koy 1580

Device Name: ImageRAYi, digital x-ray sensor system

Indications for Use: The digital x-ray sensor system, ImageRAYi, of Dental Systems, Inc. which is a subsidiary of Henry Schein Company, Inc., and its related components are used to provide instant x-ray is a suosimar of Homan oral tissue (dentin). The digital x-ray sensor system, ImageRAYi, replaces standard intraoral x-ray film and uses the same x-ray source.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use: ________ V

Over the Counter Use: _ (Per 21 CFR 801.109)

David G. Segura

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