(53 days)
None
Not Found
No
The summary mentions image processing but does not explicitly mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The software is for displaying, adjusting, measuring, printing, exporting, and storing images for diagnosis, not for treatment or therapy.
Yes
The device is intended "to support image diagnosis in medical care."
Yes
The device is described as "digital imaging software" and its intended use is to display, adjust, measure, print, export, and store digitized images. While it is used with digital imaging devices, the description focuses solely on the software's functions and does not mention any hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for displaying, adjusting, measuring, printing, exporting, and storing digitized images to support image diagnosis. This is related to in vivo imaging (images taken from within the body), not in vitro testing (tests performed on samples outside the body).
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- Mentions image processing: This is consistent with processing images from in vivo sources.
- Input Imaging Modality: "digital imaging devices" in the context of dentistry strongly suggests devices like digital X-ray machines, intraoral cameras, etc., which capture images of the patient's anatomy.
- Intended User / Care Setting: "healthcare professionals / predominantly in dentistry" further supports the use in a clinical setting for patient diagnosis based on imaging.
IVD devices are typically used to examine samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This software's function is centered around processing and managing images obtained directly from the patient.
N/A
Intended Use / Indications for 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.
Product codes
LLZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals / predominantly in dentistry
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
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 (301-796-6641).
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.
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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