CS 8100 CS 8100 ACCESS

K120975 · Trophy · MUH · Jun 22, 2012 · Dental

Device Facts

• Record ID: K120975
• Device Name: CS 8100 CS 8100 ACCESS
• Applicant: Trophy
• Product Code: MUH · Dental
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CS 8100 Access and CS 8100 are intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient. In addition, the CS 8100 is provided with a radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice acquired during an exam.

Device Story

CS 8100 Access and CS 8100 are extraoral source X-ray systems; produce tomographic digital panoramic images of dento-maxillo-facial region. Used by healthcare professionals in clinical settings for diagnostic support. CS 8100 includes radiological exam option for displaying specific segments of dental structures by exploring acquired slices. System captures X-ray data; processes into digital images for clinician review. Output assists in clinical decision-making for dental and maxillofacial diagnosis. Benefits include high-quality diagnostic imaging for pediatric and adult populations.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Extraoral source X-ray system; digital panoramic imaging; tomographic slice exploration capability; class II device (21 CFR 872.1800).

Indications for Use

Indicated for pediatric and adult patients requiring diagnostic support via tomographic digital panoramic X-ray imaging of the dento-maxillo-facial region.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Ms. Marie-Pierre Labat-Camy Regulatory Affairs Manager TROPHY 4 rue F. Pelloutier 77435 CROISSY-BEAUBOURG MARNE LA VALLEE CEDEX 2 FRANCE

Re: K120975

Trade/Device Name: CS 8100 Access CS 8100 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 30, 2012 Received: April 3, 2012

## Dear Ms. Labat-Camy:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

JUN 2 2 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as over 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 nonification. The I Driving 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 Parts 801 and 11 you don't openio da receive of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Those 1000 1000 1000 1000 1000 100 100 100 100 100 100 100 100 100 100 100 100 under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Traditional 510(k) Submission for CS 8100 Access and CS 8100

## INDICATIONS FOR USE

510(k) Number (if known):

Device Names: CS 8100 Access CS 8100

Indications for Use:

The CS 8100 Access and CS 8100 are intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.

In addition, the CS 8100 is provided with a radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice acquired during an exam.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C) ·

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)K120975

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