CS Imaging

K173622 · Trophy · LLZ · Jan 16, 2018 · Radiology

Device Facts

• Record ID: K173622
• Device Name: CS Imaging
• Applicant: Trophy
• Product Code: LLZ · Radiology
• Decision Date: Jan 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CS Imaging is digital imaging software intended to be used with Carestream Dental's digital imaging devices by healthcare professionals to display, adjust, make measurement, print, export and store digitized images to support image diagnosis in medical care, predominantly in dentistry.

Device Story

CS Imaging is digital imaging software designed for use with Carestream Dental digital imaging hardware. It functions as a medical image management and processing system. The software receives digitized image data from connected dental imaging devices. It provides tools for clinicians to display, adjust, measure, print, export, and store these images. Used in dental clinical settings, the software assists healthcare professionals in the diagnostic process by facilitating image review and manipulation. The output is a processed or measured image viewable on a workstation, which supports clinical decision-making and diagnosis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital imaging software for medical image management and processing. Operates as a software application for display, adjustment, measurement, and storage of digitized images. Intended for use with Carestream Dental digital imaging hardware. Class II device, product code LLZ.

Indications for Use

Indicated for healthcare professionals to manage, display, adjust, measure, print, export, and store digitized dental and medical images to support clinical diagnosis.

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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July 22, 2021

Trophy % Ms. Marie-Pierre Labat-Camy Global Regulatory Affairs Senior Manager 4, rue F. Pelloutier - Croissy-Beaubourg 77435 Marne la Vallée Cedex 2 FRANCE

Re: K173622

Trade/Device Name: CS Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ

Dear Ms. Labat-Camy:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 16, 2018. Specifically, FDA is updating this SE Letter due to the clearance date not appearing on the original letter (the month and year are present, but not the actual day of clearance).

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Thalia Mills, OHT7: Office of In Vitro Diagnostics and Radiological Health by email (Thalia.Mills(@fda.hhs.gov) or phone [phone]).

Sincerely,

Michael D. O'Hara For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Trophy % Ms. Marie-Pierre Labat-Camy Global Regulatory Affairs Senior Manager 4, rue F. Pelloutier - Croissy-Beaubourg 77435 Marne la Vallée Cedex 2 FRANCE

January 2018

Re: K173622

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 21, 2017 Received: November 24, 2017

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 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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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. 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)

K173622

Device Name CS Imaging

Indications for Use (Describe)

CS Imaging is digital imaging software intended to be used with Carestream Dental's digital imaging devices by healthcare professionals to display, adjust, make measurement, print, export and store digitized images to support image diagnosis in medical care, predominantly in dentistry.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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