CS 8100 3D

K133406 · Trophy · OAS · Mar 14, 2014 · Radiology

Device Facts

• Record ID: K133406
• Device Name: CS 8100 3D
• Applicant: Trophy
• Product Code: OAS · Radiology
• Decision Date: Mar 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CS 8100 3D is intended to produce or segmented tonographic digital panoramic images and three-dimensional digital X-ray images of the dento-naxillofacial area to be used at the direction of healtheare professionals as diagnostic support for pediatic and adult patients. In addition, the CS 8100 3D is provided with a radiological cram option which allows the display of one determined third molar segment of the dental structures using the capability of the system to explore cach slice acquired during an exam.

Device Story

CS 8100 3D is a computed tomography X-ray system for dental/maxillofacial imaging. Device captures digital panoramic and 3D X-ray data of dento-maxillofacial structures. System processes acquired X-ray slices to generate 2D panoramic or 3D volumetric images. Includes a radiological exam option for specific third molar segment visualization. Operated by healthcare professionals in clinical settings. Output displayed on workstation for diagnostic support. Assists clinicians in visualizing dental anatomy for treatment planning and diagnosis.

Clinical Evidence

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

Technological Characteristics

Computed tomography X-ray system; 21 CFR 892.1750; Class II; Product Codes OAS, MUH. Digital imaging sensor technology for panoramic and 3D volumetric acquisition. System supports slice-based exploration of dental structures.

Indications for Use

Indicated for pediatric and adult patients requiring diagnostic support via panoramic or 3D X-ray imaging of the dento-maxillofacial area, including third molar segment exploration.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The seal is black and white.

Public Health Service

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

March 14. 2014

Trophy A Carestream Dental Company % Marie-Pierre Labat-Camy Regulatory Affairs Manager 4 rue F. Pelloutier, Croissy-Beaubourg Marne la Vallec Cedex 2. 77435 FRANCE

Re: K133406 Trade/Device Name: CS 8100 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: December 12, 2103 Received: December 16. 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class 111 (PMA). it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Labat-Camy

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safcty/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133406

## Device Name CS 8100 3D

Indications for Use (Describe)

The CS 8100 3D is intended to produce or segmented tonographic digital panoramic images and three-dimensional digital X-ray images of the dento-naxillofacial area to be used at the direction of healtheare professionals as diagnostic support for pediatic and adult patients.

In addition, the CS 8100 3D is provided with a radiological cram option which allows the display of one determined third molar segment of the dental structures using the capability of the system to explore cach slice acquired during an exam.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smhi

FORM FDA 3881 (9/13)