(15 days)
Not Found
No
The summary describes standard digital radiography image processing and handling, with no mention of AI, ML, or related concepts.
No
The device is described as part of a radiographic system intended to acquire, process, store, display, and export digital radiographic images, which is diagnostic, not therapeutic.
No
The Philips XD-S is a workstation for acquiring, processing, storing, displaying, and exporting digital radiographic images. It is part of a radiographic system that generates images, but the device itself does not interpret or diagnose conditions from those images. Its function is to handle the images, not to provide diagnostic conclusions.
No
The device description explicitly states it is a "workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector," indicating it includes hardware components beyond just software.
Based on the provided information, the Philips XD-S is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "As a part of a radiographic system... intended to acquire, process, store, display, and export digital radiographic images." This describes a device used for medical imaging of the body, not for testing samples outside the body (in vitro).
- Device Description: The description reinforces its role within an X-ray system, dealing with X-ray images and patient data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or providing diagnostic information based on such analyses.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Philips XD-S's function is entirely focused on the acquisition and handling of radiographic images of the patient's body.
N/A
Intended Use / 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.
Product codes
LLZ
Device 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital X-Ray
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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
Roentgenstrasse 24
Hamburg, Germany D-22335 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 3003768251 |
| SUBMITTER: | Philips Medical Systems
22100 Bothell Everett Highway
Bothell, WA 98021-8431 |
| Establishment Registration No.:
Contact: | 1217116
Lynn Harmer
425-487-7312 |
| DATE PREPARED: | 11 November 2006 |
| CLASSIFICATION NAME: | System, image processing, radiological, Class I
(LLZ)
Solid State X-Ray Imager (Plat Panel/Digital
Imager), Class II (MQB) |
| COMMON/USUAL NAME: | Digital image acquisition workstation |
| TRADE/PROPRIETARY NAME: | PHILIPS XD-S Direct Radiography
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.
1
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.
2
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,
3
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
4
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 (800) 638-2041 or (240) 276-3150
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
5
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 __