(57 days)
DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
DDS software is combined with appropriate hardware to form a diagnostic review station. DDS is used to display and manipulate patient images and demographic information, for diagnostic, review and referral purposes. It is a software package which may be marketed as a software only solution, or in conjunction with standard hardware. DDS can be used as a stand-alone system or in connection with a larger system.
The provided text is a 510(k) summary for the DDS diagnostic image review station. It does not contain any information regarding acceptance criteria or the results of a study proving the device meets said criteria.
The document primarily focuses on:
- Company Information and Contact: Impax Technology Inc., Paula Pfeifle.
- Submission Date: October 18, 1999.
- Device Name: DDS (with various trade names like DS3000, RS3000, etc.).
- Common Name: Diagnostic Review Station.
- Intended Use: To display and manipulate patient images and demographic information for diagnostic, review, and referral purposes, as a software package (with or without standard hardware), and as a standalone or connected system.
- Substantial Equivalence: Comparison to Radworks Medical Imagining Software with Quality Control Module.
- Technological Comparison: Both are software packages for standard PC hardware (Windows NT), DDS also supports Unix/Solaris. Both query, retrieve, transmit medical images, provide high-quality display, and allow digital processing, measurement, and annotation.
- Non-Clinical Performance and Test Data: Stated as following "standard procedures: test plans are developed, testing is carried out through a variety of automated and manual testing, and test results are recorded and reported." It also mentions "extensively tested by programmers, quality assurance specialists, and potential customers."
- Substantial Equivalence Conclusions: The intended use and technological characteristics are equivalent to the predicate device.
- FDA Clearance Letter: Confirms 510(k) clearance (K993532) on December 15, 1999, based on substantial equivalence for the stated indications for use.
- Indications for Use Statement: Reiterates the intended use of the DDS software.
Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document describes a regulatory submission for substantial equivalence based on technological comparison and non-clinical software testing, not a clinical performance study with specific acceptance criteria and results.
§ 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).