(210 days)
The Blackford Registration Product Family consists of two components:
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A Workflow Server that calculates DICOM registration objects from CT and MR modality data, and also PET/CT data via using the CT data for registration.
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A localizer tool that works across studies, or series in the same study within a different frame of reference.
The first intended clinical use, when reading studies, is to aid navigation through, and comparative interpretation of, a target series with respect to a source series will be within a current study and the target series will be within a prior study. However they may also be within the same study but have a different frame of reference. Aiding navigation may include, but is not limited to, indicating corresponding anatomical locations, synchronized scrolling, matching orientations and/or reference lines in reformatted series and fusing two images from source and target series.
The second clinical use is to aid presentation of change between cross-sectional radiographic studies to clinical colleagues and patients.
Registration-aided interpretation of images should be carried out by a suitably qualified physician, who will base their diagnoses on training and protocols that do not necessarily rely on registration for navigation.
The Blackford Registration Product Family consists of two components:
-
A Workflow Server that calculates DICOM registration objects from CT and MR modality data, and also PET/CT data via using the CT data for registration.
-
A localizer tool that works across studies, or series in the same study within a different frame of reference.
This document is a 510(k) clearance letter for the Blackford Analysis Registration Product Family, not a study report. Therefore, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The letter acknowledges the submission and states that the device is substantially equivalent to a predicate device, meaning it has sufficiently similar indications for use and technological characteristics to market it without a full Pre-Market Approval (PMA) application. However, it does not provide the results of any performance studies.
To answer your questions, I would need access to the actual 510(k) submission document (specifically the performance testing section) or separate study reports for the Blackford Analysis Registration Product Family.
Therefore, I cannot provide the requested information based on 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).