(83 days)
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No
The summary describes basic image viewing and manipulation software, with no mention of AI, ML, or related concepts.
No
The device is described as software that enables medical professionals to view and manage cardiac patient exam records (angiographic images). It facilitates reading, viewing, printing, and exporting images, which are diagnostic support functions rather than direct therapeutic actions.
No
The device is described as software that enables viewing, printing, and exporting of cardiac patient exam records from various media. Its function is to facilitate the review and manipulation of pre-recorded data, rather than to analyze data, interpret findings, or provide a diagnosis. It acts as a viewer/management tool for existing images.
Yes
The device is described as "software" that is "installed on a PC-based system" and its function is to "read cardiac patient exam records" and enable viewing and printing of images. There is no mention of any hardware component being part of the device itself, only the platform it runs on (PC-based system) and the media it reads from.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes software that allows medical professionals to view and manage pre-recorded cardiac exam records (angiographic images). It focuses on displaying, manipulating viewing speed, printing, and exporting images.
- Lack of Diagnostic Function: There is no mention of the software performing any analysis, interpretation, or measurement of biological samples or data to provide diagnostic information about a patient's health status. IVDs are designed to provide information about a patient's condition, not just display existing data.
- Input Modality: While the input is angiographic images (which are clinical data), the software's function is to display and manage these images, not to perform a diagnostic test on them.
- No Mention of Biological Samples: IVDs typically involve the analysis of biological samples (blood, urine, tissue, etc.). This device deals with pre-recorded image data.
This device appears to be a medical image viewer and management software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The software, when installed on PC-based system, enables the medical professional to read cardiac patient exam records from preprogrammed hard disc drives and recorded, transferable media (i.e., Angiographic CINE), magnetic optical discs. The software enables motion images to be viewed at speeds of up to 60 frames per second, at slow speeds and of both still frames. The software enables the instantaneous and continuous printing of Still frames as well as the exporting of both still and dynamic images, especially when appropriate.
Product codes
LLZ
Device Description
The software, when installed on PC-based system, enables the medical professional to read cardiac patient exam records from preprogrammed hard disc drives and recorded, transferable media (i.e., Angiographic CINE), magnetic optical discs. The software enables motion images to be viewed at speeds of up to 60 frames per second, at slow speeds and of both still frames. The software enables the instantaneous and continuous printing of Still frames as well as the exporting of both still and dynamic images, especially when appropriate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Angiographic CINE
Anatomical Site
cardiac
Indicated Patient Age Range
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Intended User / Care Setting
medical professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Orug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY - 7 2012
Mr. Mark Smith Cardiology Program Manager Eastman Kodak Company Health Imaging Division 901 Elmgrove Road ROCHESTER NY 14653-5741
Re: K974086
Trade/Device Name: Kodak Digital Science Cardiac Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 27, 1997 Received: October 29, 1997
Dear Mr. Smith:
This letter corrects our substantially equivalent letter of January 20, 1998.
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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Janine M. Morr Acting 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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510(k) Number (if known): _KY7 4686
Device Name: KODAK DIGITAL SCIENCE Cardiac Viewer
Indications For Use:
The software, when installed on PC-based system, enables the medical The soltware, when installed on to accardiac patient exam records from preprofessional to read Anglographic CH-R), magnetic hard disc drives and recorded, translerable modia (f.e., Ob Tr), magine viewed at speeds of up to 60 heworks. The software enablos modion mostill frames. The software enables the Tranies per second, at slow opeous and of both still and dynaste printing of Still frames as won as the experially when appropriate.
(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use کریکی میشود. ۰۰۰۰ OR (Per 21 CFR 801.109)
Over-The-Counter Use : __________
(Optional Format 1-2-96)
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological D 510(k) Number
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