RSV (RADIOLOGY SYSTEM VISIODENT

K031448 · Visiodent SA · EHD · Jul 31, 2003 · Dental

Device Facts

• Record ID: K031448
• Device Name: RSV (RADIOLOGY SYSTEM VISIODENT
• Applicant: Visiodent SA
• Product Code: EHD · Dental
• Decision Date: Jul 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films. This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.

Device Story

RSV (Radiology System Visiodent) is a digital dental radiography system; replaces conventional x-ray film with an electronic sensor placed in the patient's mouth. Upon radiation exposure from a conventional x-ray tube, the sensor captures radiographic data; transmits to a computer for viewing, storage, printing, and image manipulation. Used in dental clinical settings by dental professionals. Provides immediate digital visualization of oral structures; facilitates diagnostic assessment; eliminates film processing time.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Extraoral source x-ray system (21 CFR 872.1800); utilizes electronic sensor for digital image capture; interfaces with computer hardware for image processing and storage.

Indications for Use

Indicated for capturing instant digital radiographic images of human oral tissue and teeth for diagnostic purposes in patients requiring dental x-rays.

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

• Trophy's RVG
• Video Dental Concept's QuickRay

Submission Summary (Full Text)

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JUL 3 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Claude D. Berthoin President VideoDental Concepts 110E Granada Blvd. Suite 207 & 208, P.O. Box 36 ORMOND BEACH FL 32175-0036 Re: K031448

Trade/Device Name: RSV (Radiology System Visiodent) Device Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: 90 EHD Dated: July 14, 2003 Received: July 21, 2003

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 (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 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. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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510(k) Number (if known): K031448

Device Name: ___________ RSV (Radiology System Visiodent

Indications For Use:

The RSV (Radiology System Visiodent) device is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional x-ray films.

This is achieved by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patient's mouth. The sensor, upon radiation exposure, automatically captures the images into a computer for viewing, storage, printing and manipulation of the x-rays.

RSV is therefore similar to Trophy's RVG and Video Dental Concept's QuickRay and several other legal systems, in its intended use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| (Per 21 CFR 801.109) | |

David A. Ingram

Reproductive, Abdomina

Over-The Counter Use

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