CS 8100SC, CS8100SC Access

K151087 · Trophy · MUH · Aug 21, 2015 · Dental

Device Facts

• Record ID: K151087
• Device Name: CS 8100SC, CS8100SC Access
• Applicant: Trophy
• Product Code: MUH · Dental
• Decision Date: Aug 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The CS 8100SC and the CS 8100SC Access are intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images to be used at the direction of healthcare professionals of the dentomaxillofacial region of the human anatomy as diagnostic support for pediatric and adult patients. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment. In addition, the CS 8100SC is provided with the panoramic 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 during an exam.

Device Story

The CS 8100SC and CS 8100SC Access are extraoral X-ray systems used by dental professionals to acquire digital panoramic and cephalometric images. The device captures tomographic digital X-ray data of the dentomaxillofacial region and hand/wrist. The system processes these inputs to generate diagnostic images for clinical review. The CS 8100SC includes a panoramic exam option allowing slice-based exploration of dental structures. These images assist clinicians in diagnostic support and growth assessment. The device is intended for use in clinical settings under the direction of healthcare professionals.

Clinical Evidence

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

Technological Characteristics

Extraoral source X-ray system; digital panoramic and cephalometric imaging; tomographic acquisition; Class II device; Product Code MUH; 21 CFR 872.1800.

Indications for Use

Indicated for pediatric and adult patients requiring dentomaxillofacial diagnostic imaging, including panoramic, cephalometric, and hand/wrist carpus imaging for growth and maturity assessment.

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

August 21, 2015

Trophy % Marie-Pierre Labat-Camy Regulatory Affairs Manager 4 Rue F. Pelloutier Croissy-beaubourg, 77435 FR

Re: K151087

Trade/Device Name: Cs 8100sc. Cs8100sc Access Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: April 20, 2015 Received: April 24, 2015

Dear Marie-Pierre 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 II (Special Controls) or class III (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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara For

Robert Ochs Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K151087

Device Name

CS 8100SC and CS 8100SC Access

Indications for Use (Describe)

The CS 8100SC and the CS 8100SC Access are intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images to be used at the direction of healthcare professionals of the dentomaxillofacial region of the human anatomy as diagnostic support for pediatric and adult patients. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.

In addition, the CS 8100SC is provided with the panoramic 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 during an exam.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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### FOR FDA USE ONLY

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

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