(81 days)
KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. R/F Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. It is not intended for use in diagnostic review for mammography.
KONICAMINOLTA DI-X1 is a software device that receives digital x-ray images and data from various sources (i.e. R/F Units, digital radiographic devices or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations.
The provided text describes a 510(k) premarket notification for the "KONICAMINOLTA DI-X1" device. It clearly states the device's indications for use and regulatory information, but it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot populate the requested tables or answer the specific questions about the device's performance evaluation.
The document is a clearance letter from the FDA, confirming the device's substantial equivalence to a predicate device, and outlining general regulatory requirements. It does not include the technical study details that would typically be found in a submission's performance section.
§ 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).