(311 days)
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Not Found
No
The summary contains no mention of AI, ML, deep learning, or any related concepts, nor does it describe any training or testing data sets which are typical for AI/ML devices.
No
The device is described as an "optional package: CT/MR MATCHING" for use in "PHILIPS EasyVision CT/MR workstations." This suggests it is a software or add-on for image processing and visualization, not a device directly used for therapy. There is no indication of therapeutic function.
No
The description mentions the device is an "optional package: CT/MR MATCHING" for use in "PHILIPS EasyVision CT/MR workstations." This suggests it's a tool for image processing or matching within a diagnostic workstation, rather than a diagnostic device itself that directly provides a diagnosis. Its function appears to be supportive of the diagnostic process, not directly diagnostic.
Unknown
The provided information is too limited to definitively determine if this is a software-only medical device. It describes an "optional package" for a workstation, which could be software, but it doesn't explicitly state it is software-only and provides no details about hardware components or dependencies.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in PHILIPS EasyVision CT/MR workstations." This describes a software package used within a medical imaging workstation, not a test performed on biological samples.
- Device Description: The description "optional package: CT/MR MATCHING" further suggests a software feature for image processing or comparison, not a diagnostic test.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes
- Diagnosis, monitoring, or screening of diseases based on biological samples
Conclusion:
The information strongly indicates that this device is a software package for use with medical imaging data (CT and MR) within a workstation. It does not appear to be designed for performing diagnostic tests on biological samples, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
CT/MR MATCHING for use in PHILIPS EasyVision CT/MR workstations
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MR
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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;
-
- 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.