Search Results

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.

Ask a specific question about this device