(58 days)
The SmartPACS™ device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
The SmartPACS™ system is a server-based software application. Smart PACS (SP) is a distributed image management system that manages the archival, retrieval, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. The SP system provides online access to patients' current and historical radiological images and relevant examination data. The system is designed for facilitating the clinical practice of radiologists and physicians. The SP system implementation is based on the Digital Imaging and Communication in Medicine (DICOM) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOMcompliant imaging devices such as CT scanners, MR imager, CR systems, and image viewing workstations.
This document does not contain information about specific acceptance criteria, device performance, or details of a study that proves the device meets such criteria.
The provided text is a 510(k) summary for the "SMARTPACS™ Picture Archiving Communications System" from Taiwan Electronic Data Processing Corporation, submitted in 2002. It includes:
- Submitter's Information: Taiwan Electronic Data Processing Corporation
- Trade Name, Common Name, and Classification: SMARTPACS™ Picture Archiving Communications System, System, Image Processing (892.2050)
- Predicate Device: MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM (K002936 from SECTRA-IMTEC AB)
- Device Description: Server-based software application for archival, retrieval, and distribution of medical images within a PACS environment, supporting DICOM.
- Indications for Use: Manipulation, management, and display of medical images from different modalities, distribution to various workstations, image storage, and printing devices using DICOM or similar standards.
- Technological Characteristics: Software server application, no patient contact, does not control life-sustaining devices. Interpretation by a physician.
- Conclusion: FDA determined substantial equivalence to the predicate device.
- A letter from the FDA confirming the 510(k) clearance (K022710).
Therefore, I cannot provide the requested information about acceptance criteria or a study's specifics because they are not present in the provided text. The document focuses on regulatory submission and clearance, not clinical performance study results or predefined acceptance metrics.
§ 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).