(64 days)
No
The document describes standard digital image processing algorithms (UnSharp Masking and Dynamic Range Reconstruction) and does not mention any AI or ML technologies.
No
This device is a digital film processing system that digitizes X-ray images, stores them, and allows for viewing and post-processing; it is not described as directly treating or diagnosing medical conditions.
No
The device is described as a "digital film processing system for reading and then digitizing X-ray images." Its function is to process, view, store, and print X-ray images, not to diagnose medical conditions. It serves as a tool for handling diagnostic images but does not perform the diagnosis itself.
No
The device description explicitly details multiple hardware components including image readers, user terminals (Pentium-based PC, keyboard, operator terminal), and workstations (SUN computers). While software is involved in processing and viewing, the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices." This is related to medical imaging, specifically radiology, not the examination of specimens derived from the human body.
- Device Description: The description details the process of converting X-ray images stored on imaging plates into digital data for viewing, processing, and storage. This is a process related to capturing and managing medical images, not performing tests on biological samples.
- Input Imaging Modality: The input modality is X-Ray, which is an imaging technique, not a method for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on the results of tests performed on these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on processing and managing medical images obtained through X-ray.
N/A
Intended Use / Indications for Use
The PCR 5.2 System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The Philips PCR system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.
Product codes (comma separated list FDA assigned to the subject device)
21CFR 892.1900
Device Description
A PCR system consists of an image reader, one or more PCR User Terminals, and an Easy Vision PCR Printstation or optional EasyVision RAD workstation.
Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the EasyVision PCR Printstation or optional EasyVision RAD workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The PCR User Terminal is used for the scheduling of patients and exams
The PCR User Terminal consists of a Pentium-based PC, a keyboard, an operator terminal with function keys, and an optional bar-code reader. PCR User Terminals may be interconnected via standard ethernet.
Three image reader types, currently AC2, AC3 and 9000, can be connected to the system in order to meet different requirements based on image plate size and throughput.. The image readers are manufactured by Fuji Photo Film Co. Ltd. The AC2 has been granted a 510(k) clearance. Refer to accession number K896050A. The AC3 has been granted a 510(k) clearance. Refer to accession number K944046. The 9000 has been granted a 510(k) clearance. Refer to accession number K951373.
The EasyVision PCR Printstation is a workstation that provides image storage, display, printing and processing functions using a SUN computer. The optional EasyVision RAD workstation is also a SUN computer that provides the same functions as the Printstation but it also provides more storage capability and additional post-processing functions. Both workstations are able to export digital images to the network via the DICOM protocol. These workstations have been granted a 510(k) clearance. Refer to accession number K953095. Digital image data from the image readers are processed based on selection of either an UnSharp Masking (UM) algorithm or a Dynamic Range Reconstruction (DRR) algorithm. The DRR algorithm is a processing feature of the PCR 5.2 system not previously available on other computed radiography systems such as the predicate device PCR ACe which uses an Unsharp Masking algorithm. The DRR algorithm provides higher transparency in radiological dense areas. The result is a display which shows more information and thus avoids alterations to the presentation parameters which would otherwise be necessary. Processing with DRR improves low contrast resolution.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Conventional X-Ray devices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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)
Reference Device(s)
K896050A, K944046, K951373, K953095
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in capital letters above a shield-like shape. Inside the shield, there are two stars and two wavy lines, creating a stylized representation of the sky and water. The logo is simple and iconic, representing the brand's identity.
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. Below the word "PHILIPS" is the handwritten text "K964124". The text is in black and the background is white.
DEC 1 8 1995
Philips Medical Systems
4 October 1996
510(K) Summary
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a 510(K) summary of safety and effectiveness for the following device.
| CLASSIFICATION NAME: | Automatic Radiographic Film Processor
(Class II, Tier 2, 21CFR 892.1900) |
|-------------------------|-----------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Computed Radiography System |
| TRADE/PROPRIETARY NAME: | Philips Computed Radiography (PCR) 5.2 |
| ESTABLISHMENT NO .: | 1217116 |
| CONTACT PERSON: | Peter Altman, Director of Regulatory Affairs |
PERFORMANCE STANDARDS:
This device complies with the relevant national and international standards for electrical safety (UL-1950. IEC-601-1, and IEC-950) as well as the international standard for electromagnetic compatibility (IEC-601-1-2) and the ACR/NEMA DICOM Version 3.0 digital imaging communication standard.
SYSTEM DESCRIPTION:
A PCR system consists of an image reader, one or more PCR User Terminals, and an Easy Vision PCR Printstation or optional EasyVision RAD workstation.
Imaging plates are exposed via conventional X-Ray devices. The imaging plates used in PCR systems are coated with a luminescent material which acts as an x-ray detector. It stores the x-ray image in the form of excited charge carriers. An exposed imaging plate is loaded into the image reader of the PCR system and the image stored on the imaging plate is scanned with a laser and converted to digital data. The digital X-ray image data is then routed to the EasyVision PCR Printstation or optional EasyVision RAD workstation for image processing, viewing, storing and/or printing to film if the workstations are connected to a compatible laser imager. The PCR User Terminal is used for the scheduling of patients and exams
The PCR User Terminal consists of a Pentium-based PC, a keyboard, an operator terminal with function keys, and an optional bar-code reader. PCR User Terminals may be interconnected via standard ethernet.
Three image reader types, currently AC2, AC3 and 9000, can be connected to the system in order to meet different requirements based on image plate size and throughput.. The image readers are manufactured by Fuji Photo Film Co. Ltd. The AC2 has been granted a 510(k) clearance. Refer to accession number K896050A. The AC3 has been granted a 510(k) clearance. Refer to accession number K944046. The 9000 has been granted a 510(k) clearance. Refer to accession number K951373.
Philips Medical Systems North America Company 710 Bridgeport Avenue Shelton, CT 06484-4708 Tel: (203) 926-7674 Fax: (203) 929-6099
1
Image /page/1/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-like emblem. The emblem features a globe-like shape with wavy lines across the middle, resembling water or sound waves. There are also four stars placed around the globe, two on the top and two on the bottom.
SYSTEM DESCRIPTION: (cont'd)
The EasyVision PCR Printstation is a workstation that provides image storage, display, printing and processing functions using a SUN computer. The optional EasyVision RAD workstation is also a SUN computer that provides the same functions as the Printstation but it also provides more storage capability and additional post-processing functions. Both workstations are able to export digital images to the network via the DICOM protocol. These workstations have been granted a 510(k) clearance. Refer to accession number K953095. Digital image data from the image readers are processed based on selection of either an UnSharp Masking (UM) algorithm or a Dynamic Range Reconstruction (DRR) algorithm. The DRR algorithm is a processing feature of the PCR 5.2 system not previously available on other computed radiography systems such as the predicate device PCR ACe which uses an Unsharp Masking algorithm. The DRR algorithm provides higher transparency in radiological dense areas. The result is a display which shows more information and thus avoids alterations to the presentation parameters which would otherwise be necessary. Processing with DRR improves low contrast resolution.
Function | Description |
---|---|
Demographic Data Entry | For each image, demographic data identifying the patient and |
describing the examination are entered. | |
Image Plate Reading | An image stored on a stimulated phosphor image plate is read |
and digitized. | |
Demographic Data Linking | Linking of demographic data to the appropriate image plate. |
Image Processing | Spatial enhancement and contrast enhancement algorithms are |
applied to digitized raw images. | |
Viewing | Images may be viewed on a monitor in order to check for |
appropriate positioning and other examination details. | |
Printing | Images may be routed to a laser hardcopy unit. |
Export | Images may be exported to other digital imaging systems, such |
as viewing stations or archives. | |
Storage | Images may be stored locally on optical disk. |
PCR 5.2 System functions are listed in the table below
INTENDED USE:
The PCR 5.2 System is a digital film processing system for reading and then digitizing X-ray images from reusable imaging plates which have been exposed in conventional radiographic examination devices. The digitized X-ray images can then be viewed, stored, post-processed and printed. The Philips PCR system can be used in all conventional RAD/RF examination situations, except for mammography. PCR is suitable for routine RAD exams as well as specialist areas, like intensive care units, trauma departments and pediatric departments.
SUBSTANTIAL EQUIVALENCE INFORMATION:
The Philips PCR 5.2 system is a modification of, and considered substantially equivalent to the Philips PCR ACe system manufactured by Philips Medical Systems based on a comparison of the technological characteristics of the PCR 5.2 system to those of the PCR ACe system. The PCR ACe system has been granted a 510(k) clearance. Refer to accession number K915237. Also, the image processing algorithm called Dynamic Range Reconstruction (DRR) used with PCR 5.2 is considered substantially equivalent to the Unsharp Mask (UM) algorithm implemented by Fuji and used with the image reader for the PCR ACe system and it is also substantially equivalent to the Dynamic Range Control (DRC) algorithm also implemented by Fuji and used on the 9000 image reader. The DRC algorithm has been granted a 510(k) clearance as part of the 9000 image reader. Refer to accession number K951373.