PHILIPS COMPUTED RADIOGRAPHY

K964124 · Philips Medical Systems, Inc. · LLZ · Dec 18, 1996 · Radiology

Device Facts

• Record ID: K964124
• Device Name: PHILIPS COMPUTED RADIOGRAPHY
• Applicant: Philips Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

System captures X-ray images via luminescent imaging plates; plates scanned by laser reader to convert latent charge carrier images into digital data. Data transmitted to workstations (EasyVision PCR Printstation or RAD) for processing, viewing, storage, and printing. Used in clinical settings (ICU, trauma, pediatrics, routine RAD) by radiology staff. Processing includes UnSharp Masking (UM) or Dynamic Range Reconstruction (DRR) algorithms to enhance image contrast and transparency in dense areas. Output allows clinicians to view, manipulate, and archive digital radiographs, facilitating diagnostic decision-making and potentially improving low-contrast resolution compared to traditional film processing.

Clinical Evidence

No clinical data provided; bench testing only. Device complies with electrical safety (UL-1950, IEC-601-1, IEC-950) and electromagnetic compatibility (IEC-601-1-2) standards.

Technological Characteristics

System components: image reader (Fuji-manufactured), PCR User Terminal (Pentium-based PC), and EasyVision workstations (SUN computer). Connectivity: Ethernet, DICOM 3.0. Image processing: UnSharp Masking (UM) and Dynamic Range Reconstruction (DRR) algorithms. Storage: Optical disk. Standards: UL-1950, IEC-601-1, IEC-950, IEC-601-1-2, ACR/NEMA DICOM 3.0.

Indications for Use

Indicated for patients undergoing conventional radiographic (RAD/RF) examinations, including routine, intensive care, trauma, and pediatric applications. Contraindicated for mammography.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Philips PCR ACe system (K915237)

Reference Devices

• AC2 image reader (K896050A)
• AC3 image reader (K944046)
• 9000 image reader (K951373)
• EasyVision workstations (K953095)

Submission Summary (Full Text)

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PHILIPS
DEC 18 1996
PHILIPS
K9641.24

# 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 EasyVision 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.

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Philips Medical Systems
North America Company
710 Bridgeport Avenue
Shelton, CT 06484-4708
Tel: [phone]
Fax: [phone]

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510(k) Summary
PCR 5.2 System
4 October 1996
PHILIPS

# 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.

PCR 5.2 System functions are listed in the table below

| 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. |

# 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.

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