CRANEX BASEX D OR CRANEX EXCEL D

K040382 · Soredex Palodex Group OY · EHD · Jul 13, 2004 · Dental

Device Facts

• Record ID: K040382
• Device Name: CRANEX BASEX D OR CRANEX EXCEL D
• Applicant: Soredex Palodex Group OY
• Product Code: EHD · Dental
• Decision Date: Jul 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.

Device Story

Cranex Basex D and Cranex Excel D are extraoral dental panoramic X-ray systems. They function by capturing X-ray projections of the dentition and oral structures, converting them into digital images using a CCD (charge-coupled device) receptor. These systems are modifications of existing Soredex film-based panoramic X-ray systems (K880982), replacing the film receptor with a digital CCD. The devices operate at fixed technique factors (65kV, 6mA DC). Used in dental clinics by trained professionals, the digital output allows clinicians to visualize oral anatomy for diagnostic purposes, facilitating clinical decision-making regarding dental and TM-joint health.

Clinical Evidence

Bench testing only. Verification and validation testing was performed to confirm the devices correspond with the intended use.

Technological Characteristics

Extraoral digital panoramic X-ray system; utilizes CCD (charge-coupled device) digital receptor; fixed technique factors (65kV anode voltage, 6mA DC current); extraoral source; digital image output.

Indications for Use

Indicated for dental radiographic examinations of dentition, TM-joints, and oral structures in patients requiring dental imaging. 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

• Orthophos DS (K983057 & K972312)

Reference Devices

• Soredex dental panoramic x-ray systems (K880982)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Soredex. The logo consists of the word "SOREDEX" in a stylized font, with a black, curved shape above it. The curved shape resembles a sail or a stylized wave.

JUL 1 3 2004

# 510(k) Summary

Kouo382

Date February 10, 2004

# Submitters Information

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

#### Trade Name

Cranex Basex D or Cranex Excel D

#### Common Name

Dental panoramic x-ray equipment, digital

#### Classification

System, X-Ray, Extraoral Source, Digital / MUH

## Predicate Device

We consider that Cranex Basex D and Cranex Excel D are substantially equivalent in design, composition and function with Orthophos DS (K983057 & K972312).

#### Product Description

Cranex Basex D and Cranex Excel D are panoramic extraoral source dental x-ray systems, which produce digital images of dentition. They are modified from the existing Soredex dental panoramic x-ray systems (K880982) by substantially replacing the film image receptor with a digital receptor(CCD). The technique factor settings are constant for the x-ray tube anode voltage (65kV) and current (6 mA DC),

#### Intended Use

The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.

## Performance data

Verification and validation testing was successfully performed to confirm that Cranex Basex D and Cranex Excel D correspond with the intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kai Lanér Soredex Instrumentarium Corporation Ekimaenkatu 22B FIN 00510 Heksinki FINLAND

Re: K040382

Trade/Device Name: Cranex Basex D or Cranex Excel D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system

Regulatory Class: II Product Code: 90 EHD Dated: June 11, 2004 Received: June 14, 2004

Dear Ms. 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.

JUL 1 3 2004

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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. Broughton

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 : KOY 0 382

Cranex Basex D and Cranex Excel D DEVICE NAME :

INDICATIONS FOR USE :

The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.

*Prescription Use*

Nancy C. Bragdon

(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
K040382
UK Number