(76 days)
The Paxera PACS is a scalable medical image and informatics system intended to receive, transmit, display, print and process digital images from medical image modality supporting the DICOM 3.0 standard, these modalities are Magnetic Resonance (MR), Computed Tomography (CT) Computed Radiography (CR), Digital X-Ray (DR), Digital Mammography (MG), X-Ray Angiography (XA), Ultrasound (US), Nuclear Medicine (NM), and Positron Emission Tomography (PT).
The Paxera PACS workstation provides the user with the ability to display, manipulate, attach diagnostic reports ,archive, transmit and print images using DICOM and other computer industry standard interfaces and standards.
Mammography images intended for primary interpretation must be acquired for an FDA approved Full Field Digital Mammography (FDDM) device. In addition, the FDDM device must be able to provide to the Paxera PACS "for presentation" a viewable DICOM image as approved by FDA for primary interpretation. If images are sent to a film printers must be FDA approved for diagnosis of digital mammography images. If digital mammography images are viewed on a display that display must be cleared by the FDA for primary diagnosis of digital mammography images.
The Paxera PACS allows for integration with many open interfaces including DICOM, Web Client, and Archiving devices. The Paxera PACS server infrastructure software facilitate database management and image management, printing, HL-7 interfacing and all DICOM services such as Store/Retrieve, Query and Send.
The Paxera PACS is intended for use by trained medical professionals including but not limited to, Radiologists, Physicians and Medical Technologists. It is the user's responsibility to ensure quality by taking measures to achieve the proper lighting conditions and image compression ratios consistent with the clinical requirements of the indented use.
The Paxera PACS is a scalable medical image and informatics system intended to receive, transmit, display, print and process digital images from medical image modality supporting the DICOM 3.0 standard... The Paxera PACS workstation provides the user with the ability to display, manipulate, attach diagnostic reports ,archive, transmit and print images using DICOM and other computer industry standard interfaces and standards. The Paxera PACS allows for integration with many open interfaces including DICOM, Web Client, and Archiving devices. The Paxera PACS server infrastructure software facilitate database management and image management, printing, HL-7 interfacing and all DICOM services such as Store/Retrieve, Query and Send.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) clearance letter for the PaxeraPACS device, indicating its substantial equivalence to a predicate device. However, it does not include data from a study describing acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or details about the training set.
The document primarily focuses on the regulatory clearance of the device for its intended use as a picture archiving and communications system, listing its functionalities and compatible modalities. It reiterates that FDA did not evaluate information related to contract liability warranties and reminds the applicant that labeling must be truthful and not misleading.
Therefore, I cannot generate the table or answer the specific questions about the study that proves the device meets acceptance criteria, as that information is not present in the provided text.
§ 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).