CS IMAGING

K113419 · Trophy · LLZ · Feb 16, 2012 · Radiology

Device Facts

• Record ID: K113419
• Device Name: CS IMAGING
• Applicant: Trophy
• Product Code: LLZ · Radiology
• Decision Date: Feb 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.

Device Story

CS Imaging is a software application designed for use with Carestream dental digital imaging systems. It functions as a Picture Archiving and Communication System (PACS) component. The software receives 2D digital images of the dento-maxillofacial region as input. It provides tools for clinicians to display, adjust (e.g., contrast, brightness), measure, print, and store these images. Used in dental clinical settings by healthcare professionals, the software facilitates image review and diagnostic support. By enabling efficient image management and manipulation, it assists practitioners in clinical decision-making regarding dental and maxillofacial health.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Software-based PACS for dental imaging. Functions include image display, adjustment, measurement, printing, and storage. Operates as a component of Carestream dental digital imaging systems. Connectivity via standard digital imaging interfaces.

Indications for Use

Indicated for healthcare professionals to display, adjust, measure, print, and store 2D digital images of the dento-maxillofacial region for diagnostic support.

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/0 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle symbol to the right of the department's name, which is arranged in a circular fashion around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle symbol is composed of three curved lines that suggest the shape of an eagle's head and wings.

## 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 - Croissy-Beaubourg 77435 MARNE LA VALLEE CEDEX 2 FRANCE

FEB 1 6 2012

Re: K113419 Trade/Device Name: CS Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 16, 2011 Received: November 18, 2011

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 comply 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

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice modiour de roo realited be n the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as bet form in the qq your device as described in your Section 510(k) premarket with and in the FDA finding of substantial equivalence of your device to a legally marketed noaticate 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 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,

Mary Pastel

Mary S. Pastel, Sc.D. 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: CS Imaging

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: CS Imaging

Indications for Use:

CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.

Prescription Use (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).

Mary S Postel

Division Sig Office of In Vitro Diagnostic Device ion and Safety

510(k) K113419

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