MYRAY SKYVIEW

K081088 · Cefla S.C. · MUH · Nov 6, 2008 · Dental

Device Facts

• Record ID: K081088
• Device Name: MYRAY SKYVIEW
• Applicant: Cefla S.C.
• Product Code: MUH · Dental
• Decision Date: Nov 6, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

This 3-D X-ray system, aka CBCT (cone beam computed tomography) is used to perform radiographic examination of the oral and maxillofacial structure. It is intended to be used in both radiology centers and average-large dental offices, specialized in implantology.

Device Story

MyRay SkyView is a 3-D cone beam computed tomography (CBCT) system; captures X-ray projections of oral and maxillofacial structures; transforms projections into 3-D volumetric images via reconstruction algorithms; used in radiology centers and dental offices; operated by dental professionals; output viewed on workstation monitors; assists clinicians in diagnostic assessment and treatment planning for dental implantology; provides high-resolution anatomical visualization for improved surgical accuracy.

Clinical Evidence

No clinical data provided; device cleared based on technological characteristics and intended use equivalence to existing extraoral source x-ray systems.

Technological Characteristics

Extraoral source X-ray system; CBCT imaging technology; 21 CFR 872.1800; Class II; Product Code MUH.

Indications for Use

Indicated for radiographic examination of oral and maxillofacial structures in patients requiring dental imaging, particularly in implantology settings.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CEFLA s.c. % Mr. Claude Berthoin President Video Dental Concept, Inc. 110 E. Granada Blvd., Suite 207 ORMOND BEACH FL 32176

Re: K081088

Trade/Device Name: MyRay SkyView Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: October 20, 2008 Received: October 21, 2008

### 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 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.

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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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

forque thi thang

Jovce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known):

K081088

Device Name:

MyRay SkyView

Indication for Use: This 3-D X-ray system, aka CBCT (cone beam computed tomography) is used to perform radiographic examination of the oral and maxillofacial structure. It is intended to be used in both radiology centers and average-large dental offices, specialized in implantology.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ton M. Whay

(Division Sign-Off) (Division Sign-Chi)
Division of Reproductive, Abdominal and Radiological Devices V 08 1088 510(k) Number -