SCANX

K013893 · Air Techniques, Inc. · MUH · Feb 1, 2002 · Dental

Device Facts

• Record ID: K013893
• Device Name: SCANX
• Applicant: Air Techniques, Inc.
• Product Code: MUH · Dental
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.

Device Story

ScanX Scanner processes photostimulable phosphor (PSP) plates used in dental radiography; replaces traditional dental x-ray film. Device scans exposed PSP plates; converts latent x-ray images into digital format. Output displayed on CRT; stored in computer memory for later retrieval. Operated by dentists and dental auxiliary personnel in clinical dental settings. Facilitates digital image management and storage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital dental imaging system; utilizes photostimulable phosphor (PSP) plates; scans plates to digitize latent x-ray images; output via CRT display and computer storage.

Indications for Use

Indicated for use by dentists and authorized dental auxiliary personnel to scan photostimulable phosphor plates exposed in place of dental x-ray film, enabling display on a CRT and storage in computer memory.

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

• VistaRay Scanner (K013893)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular with text around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

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

Re: K013893

Trade/Device Name: SCANX Scanner Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: November 20, 2001 Received: November 23, 2001

Dear Mr. Carey:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the chorosaly to regary coment date of the Medical Device Amendments, or to commence proc to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, devices that have been rochasined in assee approval of a premarket approval application (PMA). allo Costietic Act (71ct) that ao not requently of the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (see above) in Existing major regulations affecting your device can be it may be subject to additional conditions, 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 I lease oc advised that I Dris issualites our device complies with other requirements of the Act that I DA has made a acterimistions administered by other Federal agencies. You must of any I ederal battle Act's requirements, including, but not limited to: registration and listing compry with and he rece requirements, as 801); good manufacturing practice requirements as set (21 CFR Part 007), labornig (21 CFR Part 820); and if applicable, the electronic forth in the quality by stems (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 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 this 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 Additionally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on by received to promation 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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## ltem 10 STATEMENT OF INDICATIONS FOR USE:

510K Number (if known): _ KO13893

Device Name: ScanX Scanner

The ScanX Scanner is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use or Over the counter use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Air Techniques, Inc. VistaRay Scanner 510K, November 16, 2001