PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE

K063781 · Philips Medical Systems North America Co. · LLZ · Jan 5, 2007 · Radiology

Device Facts

• Record ID: K063781
• Device Name: PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE
• Applicant: Philips Medical Systems North America Co.
• Product Code: LLZ · Radiology
• Decision Date: Jan 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

As part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialists areas like intensive care, trauma, or pediatric work, excluding mammography

Device Story

Philips XD-S is a digital radiography workstation comprising a computer, keyboard, display, and mouse, integrated with a flat solid-state X-ray detector. Used by clinicians in clinical settings to preset examination data, acquire, process, store, display, and export digital X-ray images. Operates as part of a larger radiographic system including X-ray generators, tubes, and tables. Supports optional features like image stitching, touch-screen interface, and connectivity to PCR image plate readers or printers. Image processing is fully reversible and non-compressed for storage. Provides healthcare providers with digital images for diagnostic review; facilitates clinical decision-making by enabling efficient image handling and system control integration.

Clinical Evidence

Bench testing only. Device complies with federal X-Ray performance standards (CFR 1020.30, .31), electrical safety standards (UL/IEC 60950-1, 60601-1), and electromagnetic compatibility standards (IEC-601-1-2, CISPR-11).

Technological Characteristics

Workstation includes computer, keyboard, display, mouse, and flat solid-state X-ray detector. Complies with DICOM standards. Software level of concern is Minor. Risk management per ISO 14971. Connectivity includes DICOM, direct printer, and PCR plate reader interfaces.

Indications for Use

Indicated for routine radiographic examinations, including intensive care, trauma, and pediatric applications. Excludes mammography. Prescription use only.

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 Bucky Vision (K982795)
• Philips Computed Radiography (K964124)

Submission Summary (Full Text)

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K063781

## 510(k) Summary of Safety and Effectiveness

JAN -5 2007

In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a Summary of Safety and Effectiveness.

| MANUFACTURER: | Philips Medical Systems DMC GmBH<br>Roentgenstrasse 24<br>Hamburg, Germany D-22335 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 3003768251 |
| SUBMITTER: | Philips Medical Systems<br>22100 Bothell Everett Highway<br>Bothell, WA 98021-8431 |
| Establishment Registration No.:<br>Contact: | 1217116<br>Lynn Harmer<br>425-487-7312 |
| DATE PREPARED: | 11 November 2006 |
| CLASSIFICATION NAME: | System, image processing, radiological, Class I<br>(LLZ)<br>Solid State X-Ray Imager (Plat Panel/Digital<br>Imager), Class II (MQB) |
| COMMON/USUAL NAME: | Digital image acquisition workstation |
| TRADE/PROPRIETARY NAME: | PHILIPS XD-S Direct Radiography<br>Workstation/Package |

#### PERFORMANCE STANDARDS:

This device complies with the federal X-Ray performance standards (CFR I 020.30, .31) as well as with relevant national and international standards for Electrical Safety (UL 60950-1, IEC 60950-1, UL 60601-1, IEC 60601-1) as well as international standards for Electromagnetic Compatibility (IEC-601-1-2, CISPR-11) and the ACR/NEMA DICOM digital imaging communication standard.

### SYSTEM DESCRIPTION:

The Philips XD-S is a workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data, and to generate, process and handle digital X-ray images.

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As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.

The complete X-ray system would further include other subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc.

There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.

Available options are:

- touch-screen monitor .
- . image stitching
- . PCR image plate reader connection
- second flat detector .
- . X-ray generator user interface integration
- direct printer connection .

#### INTENDED USE:

As part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialists areas like intensive care, trauma, or pediatric work, excluding mammography

#### EQUIVALENCE INFORMATION:

The PHILIPS XD-S Direct Radiography Workstation/Package is considered substantially equivalent to the Philips Digital Diagnost, which received FDA marketing on November 25, 1998, under the name Philips Bucky Vision in 510(k) Number K982795.

In relation to the image plate reader connection, the PHILIPS XD-S is substantially equivalent to the Philips Computed Radiography, which received FDA marketing on December 18, 1996, under 510(k) Number K964124.

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### SAFETY INFORMATION:

The Philips XD-S Direct Radiography Workstation/Package uses mature technology. It is designed to be in compliance with National and International safety standards well as the DICOM communication standard.

lmage data are not compressed for storage and the applied image processing is fully reversible.

The software used in the Wokstation is equivalent to the software used in the predicate devices. The Level of Software concern is MINOR as determined according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May/11/2005.

A product risk mangement is cxecuted according to ISO 14971 and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.

Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence,

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Philips Medical Systems North America Company % Mr. Marc M. Mouser Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

# JAN - 5 2007

Re: K063781

Trade/Device Name: PHILIPS XD-S Direct Radiography Workstation/Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2006 Received: December 21, 2006

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the udicec use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act, The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulterstion.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial".

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kuc 378i

# Indications for Use

Kor 3781 510(k) Number (if known):

Device Name: PHILIPS XD-S Direct Radiography Workstation/Package

Indications For Use:

As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off Division of Reproductive, Abdo and Radiological Devices 510(k) Number __