ACCENT

K050693 · Air Techniques, Inc. · MUH · May 26, 2005 · Dental

Device Facts

• Record ID: K050693
• Device Name: ACCENT
• Applicant: Air Techniques, Inc.
• Product Code: MUH · Dental
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues. Accent replaces standard X-ray film and/or phosphor plate technology.

Device Story

Accent Sensor is a digital x-ray sensor system; replaces traditional x-ray film or phosphor plates. Device detects x-ray energy from an external x-ray tube; transmits data to a connected computer. System produces grayscale images for display on a monitor. Used in dental, medical, and veterinary settings. Healthcare providers use the displayed images for diagnostic purposes. Benefits include instant image acquisition compared to traditional film-based methods.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital x-ray sensor system; functions as an image receptor for external x-ray sources. Connects to a computer for data transmission. Replaces film/phosphor plate technology. Class II device (21 CFR 872.1800).

Indications for Use

Indicated for human and non-human dental, medical, and veterinary diagnostic imaging of teeth, bone, and surrounding tissues using digital x-ray sensor technology.

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/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2005

Mr. Joseph Carey Director of Quality Assurance Air Techniques, Inc. Corporate Headquarters 70 Cantiague Rock Road P.O. Box 870 HICKSVILLE NY 11801

Re: K050693 Trade/Device Name: Accent Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: May 4, 2005 Received: May 5, 2005

Dear Mr. Carey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your coursel s substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholosure) to regally mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the charmers 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 do not require approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 (Premarket n your de 10 the subject to such additional controls. Existing major regulations affecting your Apployally, it they of below 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 I toase be devilod that i 211 in that your device complies with other requirements of the Act or any I DA ilas made a acteriminations administered by other Federal agencies. You must comply with all the r carrar status and regulating, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, metaling practice requirements as set forth in the quality systems (QS) (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) This letter will allow you to begin hancellig your intil equivalence of your device to a legally premarket notification. The PDA midnig of Saccannal Systems and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our lateling regulation (21 CFR Part 801), please If you desire specific advice for your cerres on our be subjects, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to prematic notification under the Act from the Also, please note the regulation entired, "Thisonalians of your responsibilities under the Act from the 807.97). You may obtain other general mornation on your copying in the toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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## ltem 10 STATEMENT OF INDICATIONS FOR USE:

510K Number (if known): ___

Device Name: Accent

The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues.

KOSO693

Accent replaces standard X-ray film and/or phosphor plate technology.

The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.

(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)

Nancy C Brazdon

510K – Accent, March 16, 2005

(Division Sign-Off Chansion of Reproductive, Abdominal, Page 7 of 11 a .. Padiological Devices 205064 510(k) Number