CRANEX D

K043307 · Soredex Palodex Group OY · EHD · Dec 17, 2004 · Dental

Device Facts

• Record ID: K043307
• Device Name: CRANEX D
• Applicant: Soredex Palodex Group OY
• Product Code: EHD · Dental
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.

Device Story

Cranex D is a digital extraoral dental X-ray system; produces digital radiographs of dentition, TM-joints, and oral structures. Utilizes CCD digital image receptor. Operates at 57–85 kVp (panoramic) or 60–85 kVp (cephalometric) at 10 mA DC. Upgradeable for cephalometric radiography. Used in dental clinical settings by trained professionals. Provides digital images to assist clinicians in diagnostic assessment of oral anatomy. Benefits include digital image acquisition for dental diagnostics.

Clinical Evidence

Bench testing only. Verification and validation testing performed to confirm device performance corresponds to intended use.

Technological Characteristics

Extraoral dental X-ray system; digital image receptor (CCD); 57-85 kVp panoramic / 60-85 kVp cephalometric; 10 mA DC; upgradeable for cephalometric radiography.

Indications for Use

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

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 / DS Ceph (K972312)
• Cranex Basex D (K040382)
• Cranex Excel D (K040382)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Soredex. The logo features the word "SOREDEX" in a bold, sans-serif font. Above the text is a black graphic that resembles a stylized satellite dish or antenna. The overall design is simple and modern.

K043307

# 510(k) Summarv

DEC 17 2004

# Date

November 26, 2004

# Submitters Information

Soredex Instrumentarium Corporation Nahkelantie 160 FIN-04300 Tuusula Finland Phone: [phone] Fax .: Contact: Kai Lanér

# Trade Name

Cranex D

# Common Name

Dental panoramic x-ray equipment, digital, upgradeable for cephalometric radiography

# Classification

Unit, x-ray, extraoral, with timer / EHD

#### Predicate Device

We consider that Cranex D is substantially equivalent in design, composition and function with Orthophos DS / DS Ceph (K972312) and with Cranex Basex D or Cranex Excel D (K040382).

#### Product Description

Cranex D is a panoramic extraoral source dental x-ray system, which produces digital images of dentition. The device is upgradeable for cephalometric radiography. Cranex D utilizes digital image receptor(CCD).

The technique factor settings for panoramic examinations are: 57 – 85 kVp, 10 mA DC and 17.6 s max. The technique factor settings for cephalometric radiographs are: 60 - 85 kVp, 10 mA DC and 8 - 20 s.

#### Intended Use

The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto. .

#### Performance data

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

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 17 2004

Mr. Kai Lanér Soredex Instrumentarium Corporation Nahkelantie 160 FIN 00430 Tuusula FINLAND

Re: K043307 Trade/Device Name: Cranex D Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: November 26, 2004 Received: December 1, 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 (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 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 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/cdrl/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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KO43307 510 (k) NUMBER :

Cranex D DEVICE NAME :

INDICATIONS FOR USE :

.

The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.

Damil A. Shegmm

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

Prescription Use