SCAN300FP / RETROPAN (VDC)

K051664 · Oy Ajat, Ltd. · MUH · Jul 20, 2005 · Dental

Device Facts

• Record ID: K051664
• Device Name: SCAN300FP / RETROPAN (VDC)
• Applicant: Oy Ajat, Ltd.
• Product Code: MUH · Dental
• Decision Date: Jul 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Scan300fp / Retropan (VDC) Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.

Device Story

Scan300fp/Retropan is a digital X-ray conversion kit for dental imaging; replaces conventional film. Device uses a sensor to capture X-ray signals; converts to instant digital images. System connects to DentalEye software (K012439) for post-processing and image enhancement. Used in dental clinics by dental professionals. Benefits include reduced patient radiation exposure due to lower required exposure times and faster workflow by eliminating chemical film processing. Clinicians view images on a computer display to assist in diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital X-ray conversion kit; sensor-based imaging; connects to external software for image processing; replaces conventional film-based X-ray systems; operates as an extraoral source X-ray system.

Indications for Use

Indicated for dental patients requiring oral tissue and tooth x-ray imaging.

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.

Reference Devices

• DentalEye software (K012439)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the circle.

JUL 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oy AJAT, Ltd. % Mr. Claude D. Berthoin President Video Dental Concepts, Inc. 110 E Granada Blvd., Suite 207 ORMOND BEACH FL 32176

Re: K051664 Trade/Device Name: Scan300fp/Retropan (VDC) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 20, 2005 Received: June 24, 2005

Dear Mr. Berthoin:

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 (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 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 system (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 promated 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 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 premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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510(k) number: (if known): __ Kos 1664 _______________________________________________________________________________________________________________________________________

Scan300fp / Retropan (VDC) Device Name: _________________________________________________________________________________________________________________________________________________________________

## INDICATIONS FOR USE:

The Scan300fp / Retropan (VDC) Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.

The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K012439, which gives post processing capabilities to enhance images.

lt is faster to obtain images with the Scan300fp / Retrofit (VDC) than with conventional film since no chemical nor any other type of processing is required.

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

CONCURANCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

| Prescription Use: | ✓ | OR | Over-the-Counter Use |
|----------------------|---------------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |
| | Nancy C Brogdon | | |
| | (Division Sign-Off) | | |
| | Division of Reproductive, Abdominal, and Radiological Devices | | |
| 510(k) Number | K051664 | | |