(88 days)
The KODAK Digital Science Pro-Medical Thermal Printer is intended to produce continuous tone, photographic quality hard copy output that closely match electronically created or stored images viewed on a CRT display. The device will create either prints or transparencies from digital images acquired from image transmission networks or directly from digital capture or storage devices. The printer accepts digital images in common Raster and POSTSCRIPT formats.
The KODAK Digital Science Pro-Medical Thermal Printer is intended to produce continuous tone, photographic quality hard copy output that closely match electronically created or stored images viewed on a CRT display. The device will create either prints or transparencies from digital images acquired from image transmission networks or directly from digital capture or storage devices. The printer accepts digital images in common Raster and POSTSCRIPT formats. The device does not employ any form of lossy data compression.
The provided document is a 510(k) clearance letter from the FDA for a Kodak Digital Science Pro-Medical Thermal Printer. This type of device is a hardcopy output device, not an AI/ML-driven diagnostic or analytical tool.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this device.
The clearance letter focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for non-AI medical devices. It confirms that the printer is intended to produce high-quality hard copies of medical images from digital sources.
§ 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).