(84 days)
RamSoft PACS software is used with general purpose computing hardware to acquire, transmit, store and display images for clinical purposes. RamSoft PACS consists of one or more of image server, web server, database server, and workstations for interpretation, clinical review, quality control, video capturing, film digitizing, document scanning. Images may be acquired from imaging devices such as CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.
RamSoft PACS is a stand-alone software package that is used on general purpose computing hardware. As long as minimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform. The software allows digital image processing, measurement, communication, and storage.
The provided text describes RamSoft PACS, a Picture Archiving and Communication System, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a clinical or technical study against acceptance criteria.
Here's a breakdown of why this information is missing, based on the provided text:
- Intended Use and Description: The document states the software's purpose (acquire, transmit, store, and display images) and that it is "tested according to the specifications that are documented in a RamSoft PACS System Test Plan." However, the details of these specifications (acceptance criteria) and the results of such testing are not included.
- Substantial Equivalence: The core of this 510(k) summary is the comparison table to predicate devices (RamSoft Ultrapro 98, Kodak AutoRad, GE Advantage). This table focuses on functional equivalency (e.g., "Print to paper: Yes," "Graphical UI: Yes," "Image input: DICOM 3.0"). This is a comparison of features, not a performance study.
- Conclusion: The document explicitly states: "The determination of substantial equivalence is not based on an assessment of performance tests." This directly indicates that the information you are requesting (a study proving device performance against acceptance criteria) was not part of this particular submission for FDA clearance.
- Level of Concern: The document mentions "failure or latent design flaw would not be expected to result in death or injury to a patient," classifying the "Level of Concern" as "minor." This relates to risk assessment, not device performance metrics.
Therefore, I cannot provide the requested information from the given text because it is not present. The document focuses on demonstrating substantial equivalence in features and intended use to already cleared devices, rather than presenting a performance study against acceptance criteria for the RamSoft PACS.
§ 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).