(137 days)
No
The summary describes a standard digital X-ray detector and workstation, focusing on image acquisition and conversion. There is no mention of AI, ML, or any advanced image processing that would typically involve these technologies.
No
The device is an X-ray imaging device used for acquiring digital radiographic images for diagnosis, not for treating conditions.
Yes
The device converts x-ray patterns into electrical signals which are then used to create visible images for medical diagnosis, and performance studies confirm its diagnostic capability.
No
The device description clearly states it is a "Solid State X-ray Imaging Device" that converts x-ray patterns into electrical signals using a scintillator and photodetectors. This involves significant hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Pixium 4343RC is a component of a radiographic system. Its function is to acquire digital radiographic images by converting X-ray patterns into electrical signals, which are then converted into visible images for medical diagnosis.
- Input: The input is X-ray radiation passing through the patient's body, not a biological sample taken from the body.
- Output: The output is a digital image, not a test result derived from analyzing a biological sample.
The device is clearly an in vivo diagnostic imaging device, as it is used to image the inside of a living patient's body using X-rays.
N/A
Intended Use / Indications for Use
As a part of a radiographic system, the Pixium 4343RC is intended to acquire digital radiographic images. The Pixium 4343RC is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
The Pixium 4343RC is a Solid State X-ray Imaging Device that converts x-ray patterns into electrical signals are converted into visible images for use in medical diagnosis. In the device, a cesium iodide scintillator absorbs the input x-ray photons. The scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal.
The detector is permanently installed and intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct x-ray imaging. It is electrically powered and connected with the x-ray system. The device is connected to the Philips XD-S Eleva Radiography Workstation to create a complete x-ray imaging chain, and it is intended to be used exclusively in the Philips Digital Diagnost x-ray system, one of the predicate devices.
- Detector Size: 500 x 490 x 45,5 mm3 .
- Image Size (Pixel): 2840 x 2874 .
- Pixel Size: 148 um .
- Image Resolution up to 3.4 LP/mm .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
The Pixium 4343RC is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
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)
A concurrence study according to CDRH's Guidance for the Submission of 510(k) 's for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the Philips Pixium 4343RC integrated with the Philips Bucky System provides images of equivalent diagnostic capability to the predicate radiographic system, the Philips BuckyVision integrated with the Trixell Pixium 4600 Stationary Detector, and its results demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K123005, K06371, K931071, K063781
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)
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K131483
Page 1 of 7
PHILIPS
5. 510(k) Summary
Type of submission: Traditional 510(k)
Date of Submission: Hamburg, 13 May 2013 Original Submission Date
Name and Address of Manufacturer and 510(k) Owner:
Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 22335 Hamburg GERMANY Establishment registration number: 3003768251 Contact: Gerold Schwarz, Regulatory Affairs Manager North America Tel.: +49 40 5078-1116 Fax: +49 40 5078-2022
US contact person:
Jennifer Cartledge REU Associates Inc. 409 Woodridge Drive Seneca, SC 29672 Tel.: (864) 500-0097 Email: jcartledge@reuassociates.com
Device Identification
OCT 0 7 2013
| Trade Name: | Philips Pixium 4343RC |
|---|---|
| Model number: | PX4343RC |
| Common names: | Stationary X-Ray System |
| Classification(s) of the device: | Stationary X-Ray System, 21CFR 892.1680, |
| Product Code: MQB, | |
| Classification Panel: 90 - Radiology, | |
| Class II |
Equivalent legally marketed devices:
Philips Bucky Vision. K982795 (introducing the Trixell Pixium 4600 Stationary Solid State X-ray Imager). The Bucky Vision system is also marketed under the commercial name of Digital Diagnost.
Philips Wireless Portable Detector FD-W17, K090625
1
Device Description:
The Pixium 4343RC is a Solid State X-ray Imaging Device that converts x-ray patterns into electrical signals are converted into visible images for use in medical diagnosis. In the device, a cesium iodide scintillator absorbs the input x-ray photons. The scintillator in turn emits visible spectrum photons that illuminate an array of photodetectors that create an electrical charge representation of the x-ray input. A matrix scan of the array converts the integrated charges into a modulated electrical signal.
The detector is permanently installed and intended to be integrated into an x-ray system, where it constitutes an x-ray receptor for direct x-ray imaging. It is electrically powered and connected with the x-ray system. The device is connected to the Philips XD-S Eleva Radiography Workstation to create a complete x-ray imaging chain, and it is intended to be used exclusively in the Philips Digital Diagnost x-ray system, one of the predicate devices.
- Detector Size: 500 x 490 x 45,5 mm3 .
- Image Size (Pixel): 2840 x 2874 .
- Pixel Size: 148 um .
- Image Resolution up to 3.4 LP/mm .
An identical Solid State X-Ray Imager has received pre- market clearance, under K 123005 (December 7, 2012), for use with the Swissray medical AG x-ray system.
Intended Use:
The Indication for Use for the Philips Pixium 4343RC is identical to that of the predicate, the Wireless Portable Detector FD-W17 and is as follows:
As a part of a radiographic system, the Pixium 4343RC is intended to acquire digital radiographic images. The Pixium 4343RC is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
The Philips BuckyVision System (K982795) is a radiography system introducing a Pixium 4600 Solid State X-Ray Imager. The Philips Wireless Portable Detector FD-W17 (K090625) is a typical digital radiography imaging chain consisting of a Solid State X-Ray Imager, and the image processing software XD-S Eleva Workstation that has received pre-market clearance under the pre-market notification number K06371. The Philips Wireless Portable Detector FD-W17 is cleared for use with the Philips Bucky Vision System, along with clearance for use with other Philips Radiography Systems. The Philips Pixium 4343RC is a typical digital radiography imaging chain consisting of a Solid State X-Ray Imager Pixium 4343RC and the image processing software XD-S Eleva Workstation. The x-ray imager Pixium 4343RC functions equivalently to the Pixium 4600 solid state x-ray detector in the BuckVision System.
This is the first Philips 510(k) Premarket Notification for the Philips Pixium 4343RC. and there have been no previous Philips submissions for the Philips Pixium 4343RC'.
2
however, an identical detector (Pixium 4343RC) has received pre- market clearance by Swissray Medical AG for use with their x-ray system, under pre-market notification number K 123005, issued in December of 2012.
Summary of technological characteristics / non-clinical testing and performance data:
This modified device has the same indications for use and technological characteristics as the predicate devices. Comparisons of the following technological characteristics, and non-clinical performance data (indicated by *), were assessed, and the results demonstrate the substantial equivalence to the predicates:
| | Predicate Device:
Pixium 4600
Detector | Predicate Device:
FD-W17 | New Device: Pixium
4343RC | Discussion |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 510(k) Number | K982795 (Philips
Bucky Vision also
known as the
Digital Diagnost) | K090625 (Philips
Wireless Portable
Detector FD-W17) | N/A | N/A |
| Description | Detector, part of
Philips Digital
Diagnost
(previously
"Bucky Vision") | Detector, part of
Philips Digital
Diagnost (previously
"Bucky Vision") | Detector, part of
Philips Digital
Diagnost (previously
"Bucky Vision") | Identical |
| Device Type | Solid State X-Ray
Imager (MQB) | Solid State X-Ray
Imager (MQB) | Solid State X-Ray
Imager (MQB) | Identical |
| 510(k) Owner | Philips Medical
Systems DMC,
Hamburg,
Germany | Philips Medical
Systems DMC,
Hamburg, Germany | Philips Medical
Systems DMC,
Hamburg, Germany | Identical |
| Indications for
Use | The Philips Bucky
Vision is intended
for use in general
radiographic
examinations and
applications
wherever
conventional
screen-film
systems may be
used (excluding
fluoroscopy,
angiography, and
mammography) | As a part of a
radiographic system,
the Wireless
Portable Detector
FD-W17 is intended
to acquire digital
radiographic images.
The Wireless
Portable Detector
FD-W17 is suitable
for all routine
radiography exams,
including specialist
areas like intensive
care, trauma, or
pediatric work | As a part of a
radiographic system,
the Pixium 4343RC is
intended to acquire
digital radiographic
images. The Pixium
4343RC is suitable for
all routine radiography
exams, including
specialist areas like
intensive care, trauma,
or pediatric work,
excluding fluoroscopy,
angiography and
mammography. | Identical /
Equivalent |
| | Predicate Device:
Pixium 4600
Detector | Predicate Device:
FD-W17 | New Device: Pixium
4343RC | Discussion |
| | | excluding
fluoroscopy,
angiography and
mammography. | | |
| X-Ray
Absorber | CsI Scintillator | CsI Scintillator | CsI Scintillator | Identical |
| Installation
type | Stationary,
permanently
installed | Portable | Stationary,
permanently installed | Identical |
| Readout
Mechanism | Switching Diode | Thin Film Transistor | Thin Film Transistor | Equivalent |
| Detector Size | 533 x 488 x 45.5
mm³ | 489 x 466 x 25 mm³ | 500 x 490 x 45.5 mm³ | Equivalent |
| Detector
Weight | 17.8 kg | * NRTL certified compliance
6
K131483
Page 7 of 7
- 0 ISO 14971 Second edition 2007-03-01 - Medical devices - Application of risk management to medical devices
- IEC 60601-1-3 Edition 2.0 2008-01 Medical electrical equipment Part I-3: . General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
- IEC 62304 First edition 2006-05 Medical device software Software life . cycle processes
- IEC 60601-2-54 Edition 1.0 2009-06 Medical electrical equipment Part 2-. 54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography ad radioscopy
- . IEC 62220-1 Edition 1.0 (2003-10) - Medical electrical equipment -Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
Conclusion:
The comparison of technological characteristics, non-clinical performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.
Philips Medical Systems concludes that the device is substantially equivalent to the currently legally marketed predicate devices. The Pixium 4343RC does not introduce new indications for use or intended use, has identical or equivalent technological characteristics, provides images of equivalent diagnostic capability, and does not introduce new potential hazards or safety risks. The device is as safe, as effective, and performs as well or better than the predicate devices.
7
Image /page/7/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned above a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7. 2013
Philips Medical Systems DMC GmbH % Ms. Jennifer Carledge REU Associates, Inc. 409 Woodridge Drive SENECA SC 29672
Re: K131483
Trade/Device Name: Philips Pixium 4343RC Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 27, 2013 Received: September 9, 2013 .
Dear Ms. Cartledge:
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 indications for 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 10 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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.
8
Page 2-Ms. Cartledge
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pan 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.h.7)
ਿੱ
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
4. Indications for Use
K131483 510(k) Number (if known):
Device Name:
Philips Pixium 4343RC' Model:4343RC
:
Indications For Use:
As a part of a radiographic system, the Pixium 4343RC is intended to acquire digital radiographic images. The Pixium 4343RC is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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(Division Sign-OM) Division of Radiological Health Office of In I'iro Diagnostics and Radiological Health
K131483 510(k)
Philips Pixium 4343RC Premarket Notification - Traditional 510(k) 4. Indications for Use Statement
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