MINRAY

K033755 · Soredex Palodex Group OY · EHD · Apr 29, 2004 · Dental

Device Facts

• Record ID: K033755
• Device Name: MINRAY
• Applicant: Soredex Palodex Group OY
• Product Code: EHD · Dental
• Decision Date: Apr 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Minray dental x-ray system is intended to be used for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intraoral digital or film image receptor media.

Device Story

Minray is an extraoral dental X-ray system. It generates X-rays to produce images of dentition, jaws, and oral structures on intraoral digital or film receptors. The system utilizes a high-frequency X-ray generator with DC output, offering selectable anode voltages of 60 kV or 70 kV and a constant anode current of 7 mA. Exposure times range from 20 ms to 3.2 s. Operated by dental professionals in a clinical setting, the device provides radiographic output used for diagnostic dental examinations. The system aids clinicians in visualizing oral anatomy to support clinical decision-making and patient care.

Clinical Evidence

Bench testing only. Verification and validation testing were performed to confirm the device corresponds with its intended use.

Technological Characteristics

Extraoral dental X-ray system; high-frequency generator with DC output; selectable anode voltages (60 kV, 70 kV); constant anode current (7 mA); exposure time range 20 ms to 3.2 s; intended for use with intraoral digital or film receptors.

Indications for Use

Indicated for dental radiographic examinations of dentition, jaws, and oral structures using intraoral film or digital image receptors. Prescription use only.

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

• Heliodent DS (K960819)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SOREDEX" in a stylized font. To the left of the word is the date "APR 2 9 2004". The text is black and the background is white. The image appears to be a logo or heading from a document.

## 510(k) Summary

KO33755

Date November 27, 2003

#### Submitters Information

Soredex Instrumentarium Corporation Elimaenkatu 22 00510 Helsinki Finland Phone: [phone] Fax .: [phone] Contact: Kai Lanér

Trade Name Minray

Common Name Dental X-ray System

#### Classification

Unit, X-ray, Extraoral with Timer / EHD

#### Predicate Device

We consider that Minray is substantially equivalent in design, composition and function with Heliodent DS (K960819).

#### Product Description

Minray is an extraoral source dental x-ray system, which produces dental images on intraoral digital or film image receptors. The x-ray generator operates on high frequency and has an DC output. There are two selectable anode voltages 60 kV and 70 kV. Anode current is constant 7 mA. Exposure time can be selected from 20 ms to 3.2 s.

#### Intended Use

The Minray dental x-ray system is intended to be used for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intraoral digital or film image receptor media.

### Performance data

Verification and validation testing was successfully performed to confirm that Minrav corresponds with the intended use.

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Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 9 2004

Mr. Kai Lanér Soredex Instrumentarium Corporation Elimäenkatu 22 B, Helsinki P.O. Box 250 00031 Sordex FINLAND

Re: K033755 Trade/Device Name: Minray Dental X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II

Product Code: 90 EHD Dated: March 10, 2004 Received: March 12, 2004

Dear Mr. Lanér

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. 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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#### K033755 510 (k) NUMBER :

MINRAY DEVICE NAME :

INDICATIONS FOR USE :

:

.

The Minray dental x-ray system is indicated for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intra oral film or digital image receptor media.

**Prescription Use**
(Per 21 CFR 801.109)

Daniel A. Lynn

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .