(311 days)
Not Found
optional package: CT/MR MATCHING
This document is a 510(k) summary for Philips Medical Systems' "CT/MR MATCHING for use in PHILIPS EasyVision CT/MR workstations." It focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating the device meets such criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily makes high-level claims about safety and effectiveness based on past experience and user information, rather than detailing a specific performance study with acceptance criteria and results.
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K95-3911//
Image /page/0/Picture/1 description: The image shows a date written in bold, black font. The date is "JUN 27 1996". The month is abbreviated, followed by the day and year. The text is clear and easily readable.
Philips Medical Sys
P.O. Box 10000, 5680 DA
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.
Quality Assurance Dpt. XSB/XCB XB030-950608/RR/wp
1995.05.30
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for the optional package:
CT/MR MATCHING
for use in PHILIPS EasyVision CT/MR workstations
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The undersigned certifies that the 510(k) Pre-Market notification for the above referenced products contains adequate information and data to enable CDRH to determine substantial equivalence.
This information and data is summarized as follows:
- ﻨﺴﻴ The information for Users contains comprehensive information to insure safe and effective use;
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- Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users.
R. W.Rijntjes
Approbation Officer
Quality Assurance dept. XSB / XCB
Philips Medical Systems, Best
The Netherlands.
nilips Medical Systems Neder noluis 6. Best The Neth 31 40 76 22 05 Commercial Register Eindhoven no.
§ 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).