(30 days)
Kodak Radiation Oncology Software / for ACR systems is intended to utilize a scanner and software interface to digitize computed radiography exposed phosphor plates. Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application. Kodak Radiation Oncology Software / for ACR systems enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class.
The Kodak Radiation Oncology Software / for ACR systems enables digitization of computed radiography exposed phosphor plates for acquiring portal (localization and verification) images and simulation images. The device enables capture, processing, viewing and transmission of DICOM 3.0 compliant images for printing, archiving or display. Image review tools are included that enable the user to adjust, magnify, and annotate the images. The Kodak Radiation Oncology Software / for ACR systems is dedicated specifically for use with Kodak ACR products. Kodak Radiation Oncology Software / for ACR systems utilizes a scanner and software interface to digitize computed radiography exposed phosphor plates. Kodak Radiation Oncology Software / for ACR systems is DICOM 3.0 compliant radiological digitization application. Kodak Radiation Oncology Software / for ACR systems is enables the user to autoarchive lossless or lossy compressed images locally or at a remote archive site. Supports DICOM 3.0 Query and Retrieve Service Class
This submission is a 510(k) for a software device, the Kodak Radiation Oncology Software, and does not contain information about acceptance criteria or a study proving that the device meets such criteria. A 510(k) notification aims to demonstrate substantial equivalence to a legally marketed predicate device, primarily through a comparison of technological characteristics and intended use, rather than through a performance study against predefined acceptance criteria for clinical outcomes.
The document provided details:
- Device Name: Kodak Radiation Oncology Software / for ACR systems
- Intended Use: To utilize a scanner and software interface to digitize computed radiography exposed phosphor plates. It is a DICOM 3.0 compliant radiological digitization application that enables users to autoarchive lossless or lossy compressed images locally or remotely and supports DICOM 3.0 Query and Retrieve Service Class.
- Predicate Device: DI-2000 DICOM CLIENT (K980213).
- Comparison: The key aspects of the submission are the comparison of features between the Kodak Radiation Oncology Software and its predicate device, as shown in Table 1. This table indicates equivalent functionalities and some enhancements in the Kodak software (e.g., acquiring portal localization, verification, and simulation images, annotating DICOM images).
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment as such details are not present in this 510(k) summary. The submission focuses on substantial equivalence based on functional and technical comparisons rather than performance against clinical acceptance criteria.
§ 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).