(81 days)
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No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe any characteristics typically associated with AI/ML devices like training/test sets or performance metrics derived from such models.
No
The device is described as an "optional package: SPINE" for use in "PHILIPS Easy Vision X-Ray workstations" and mentions "image processing" for "X-Ray" images of the "SPINE". This indicates it is likely a software or hardware component for medical imaging and diagnosis, not a device used for treatment or therapy.
No
The provided text describes the device as an "optional package: SPINE" for "PHILIPS Easy Vision X-Ray workstations" and mentions "X-Ray" as the "Input Imaging Modality" and "SPINE" as the "Anatomical Site." There is no indication that the device performs any diagnosis; it appears to be a component or feature of an X-ray workstation that processes images of the spine.
No
The summary describes an "optional package: SPINE" for "PHILIPS Easy Vision X-Ray workstations." This strongly suggests a software component that enhances the functionality of existing X-Ray hardware, rather than a standalone software-only medical device. The lack of information about the software itself and the focus on the workstation context further supports this.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases or other conditions. They are used outside of the body.
- Device Description: The description indicates the device is an "optional package: SPINE" for use in "PHILIPS Easy Vision X-Ray workstations". This strongly suggests it is a software or feature related to processing or viewing X-ray images of the spine.
- Input Modality: The input modality is "X-Ray", which is an imaging technique performed on the patient's body, not on a sample taken from the body.
- Anatomical Site: The anatomical site is "SPINE", further reinforcing that it deals with imaging of a body part.
There is no mention of analyzing biological samples or performing tests on materials outside the body, which are the hallmarks of an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Philips Medical Systems
P.O. Box 10000. 5680 DA Best. The Netherlands
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.
K963980
DEC 23 1996
QA Department XRD Best XBQ87-960792/HD/wp
1996.05.20
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for the optional package:
SPINE
for use in PHILIPS Easy Vision X-Ray 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:
- The information for Users contains comprehensive information to insure safe and 1. effective use;
- Past experience with substantially equivalent predicate devices/methods has shown 2. 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.
lips Medical Systems Nederlar pluis 6, Best. The Netherla 31 40 27 911 11 Fax: +31 40 27 622 05 Commercial Register Eindhoven no. 17060498