CS 3D Imaging

K151837 · Trophy · LLZ · Aug 19, 2015 · Radiology

Device Facts

• Record ID: K151837
• Device Name: CS 3D Imaging
• Applicant: Trophy
• Product Code: LLZ · Radiology
• Decision Date: Aug 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CS 3D Imaging is digital imaging software intended to be used with Carestream's 3D extra-oral X-ray equipment by healthcare professionals to display, make measurement, print, export and store 2D and 3D views of the dento-maxillofacial and ENT (Earn, Nose and Throat) region of the human anatomy as diagnostic support. It is also a software application used for the management of the implant library and the virtual placement of dental implants. It can be used as stand-alone software in a standard computer and does not perform any radiographic image acquisition.

Device Story

CS 3D Imaging is a software application for viewing and analyzing 3D extra-oral X-ray data; inputs include digital image files from Carestream 3D equipment. Software enables display, measurement, printing, exporting, and storage of 2D/3D dento-maxillofacial and ENT anatomy images. Includes tools for dental implant library management and virtual implant placement. Used by healthcare professionals in clinical settings on standard computers. Does not perform image acquisition. Output serves as diagnostic support for treatment planning and implant positioning.

Clinical Evidence

No clinical data provided; device is software for image display and measurement.

Technological Characteristics

Digital imaging software for 2D/3D visualization and measurement. Operates on standard computer hardware. Standalone application. No image acquisition hardware included.

Indications for Use

Indicated for healthcare professionals to display, measure, print, export, and store 2D/3D images of dento-maxillofacial and ENT anatomy for diagnostic support and virtual dental implant placement. No specific age or gender contraindications stated.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is in a sans-serif font.

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

August 19. 2015

TROPHY % Ms. Marie-Pierre Labat-Camy Regulatory Affairs Manager 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG 77435 FR

Re: K151837

Trade/Device Name: CS 3D Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 3, 2015 Received: July 6, 2015

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 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 device-related adverse events) (21 CFR 803); 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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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/Resourcesfor 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/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, Ph.D. 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)

K151837

Device Name CS 3D Imaging

## Indications for Use (Describe)

CS 3D Imaging is digital imaging software intended to be used with Carestream's 3D extra-oral X-ray equipment by healthcare professionals to display, make measurement, print, export and store 2D and 3D views of the dento-maxillofacial and ENT (Earn, Nose and Throat) region of the human anatomy as diagnostic support.

It is also a software application used for the management of the implant library and the virtual placement of dental implants.

It can be used as stand-alone software in a standard computer and does not perform any radiographic image acquisition.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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