Who is the manufacturer of PHILIPS PIXIUM 4343RC?

Philips Medical Systems Dmc GmbH filed the 510(k) submission for PHILIPS PIXIUM 4343RC (K131483).

What is the FDA product code for PHILIPS PIXIUM 4343RC?

MQB. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for PHILIPS PIXIUM 4343RC?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PHILIPS PIXIUM 4343RC?

Philips Bucky Vision (K982795); Philips Wireless Portable Detector FD-W17 (K090625).

Who can help prepare an FDA 510(k) submission like PHILIPS PIXIUM 4343RC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PHILIPS PIXIUM 4343RC

K131483 · Philips Medical Systems Dmc GmbH · MQB · Oct 7, 2013 · Radiology

Device Facts

Record ID	K131483
Device Name	PHILIPS PIXIUM 4343RC
Applicant	Philips Medical Systems Dmc GmbH
Product Code	MQB · Radiology
Decision Date	Oct 7, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

Pixium 4343RC is a stationary solid-state X-ray imaging detector integrated into Philips Digital Diagnost systems. It uses a cesium iodide (CsI) scintillator to absorb X-ray photons, converting them into visible light, which is then captured by a photodetector array and converted into electrical signals. The device is permanently installed in clinical radiography suites and operated by trained radiology staff. It connects to the Philips XD-S Eleva Radiography Workstation for image processing and display. The output provides digital radiographic images for clinical diagnosis, aiding healthcare providers in evaluating patient anatomy and pathology. The device benefits patients by enabling high-quality digital imaging for routine, trauma, and pediatric exams.

Clinical Evidence

A clinical concurrence study was conducted in accordance with CDRH guidance for solid-state X-ray imaging devices. The study compared images acquired by the Pixium 4343RC to those from the predicate Philips BuckyVision system (using the Trixell Pixium 4600 detector). Results demonstrated that the Pixium 4343RC provides images of equivalent diagnostic capability.

Technological Characteristics

Solid-state X-ray imager; CsI(Tl) scintillator; thin-film transistor (TFT) readout; 148 µm pixel size; 16-bit ADC; 100 Mbit/s Ethernet interface. Stationary installation. Complies with ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 62304, IEC 60601-2-54, and IEC 62220-1 standards.

Indications for Use

Indicated for patients requiring routine radiographic exams, including intensive care, trauma, and pediatric applications. Contraindicated for fluoroscopy, angiography, and mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Philips Bucky Vision (K982795)
Philips Wireless Portable Detector FD-W17 (K090625)

Reference Devices

Trixell Pixium 4600 Stationary Solid State X-ray Imager (K982795)
Philips XD-S Eleva Workstation (K063781)
Philips Thoravision (K931071)
Swissray medical AG x-ray system (K123005)

Submission Summary (Full Text)

{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 | <5.1 kg | <14 kg | Equivalent | | Image Size (Pixel) | 3001 x 3001 | 3000 x 2400 | 2840 x 2874 | Equivalent | | Image Size (X- ray field) | 429 x 429 mm² | 432 x 341.1 mm² | 420 x 425 mm² | Equivalent | | Distance Image to Rim | 27.5 mm | 28.2 mm | 34.9 mm | Equivalent | | Pixel Size | 143 µm | 144 µm | 148 µm | Equivalent | | Nyquist Frequency: | 3.50 lp/mm | 3.47 lp/mm | 3.37 lp/mm | Equivalent | | ADC Digitisation | 14 bit | 16 bit | 16 bit | Equivalent | | Maximum X- ray Dose for Linear Response | 30 µGy | 50 µGy | 50 µGy | Equivalent | | Maximum Usable Dose | 60 µGy | 75 µGy | 85 µGy | Equivalent | | Number of Modes | 5 | 1 | 2 | Equivalent | | Exposure Window Durations | 0.5 s, 1.0 s, 2.0 s, 3.2 s, 4 s | 1-8192 ms | 1-8192 ms | Equivalent | | Image Data | 19.24 MBytes | 14.4 MBytes | 16.3 MBytes | Equivalent | | Scintillator | 500 µm CsI(Tl), glued | 500-600 µm CsI(TI), glued | 500-600 µm CsI(Tl), glued | Equivalent | | Use w and w/o Radiographic Grid? | Yes | Yes | Yes | Identical | | Maximum | 100 Gy | 100 Gy | 100 Gy | Identical | | | Predicate Device: Pixium 4600 Detector | Predicate Device: FD-W17 | New Device: Pixium 4343RC | Discussion | | Lifetime Dose | 4 h | 2 h | 4 h | Identical | | Warm-up Duration before Calibration | | | | | | Digital Subtraction Angiography (DSA) | None (exempt from intended use) | None (exempt from intended use) | None (exempt from intended use) | Identical | | Positioning Mode | None | None | None | Identical | | Stitching Mode (Implemented in Detector) | None | None | None | Identical | | Binning | None (1 x 1) | None (1 x 1) | None (1 x 1) | Identical | | Framespeed: Dynamic Imaging – Pulsed | None | None | None | Identical | | Data Interface to Workstation | Taxi | 100 Mbit/s Ethernet | 100 Mbit/s Ethernet | Equivalent | | Power Consumption | 18 W | 10 W | 20.4 W | Equivalent | | Modulation Transfer Function (MTF) | 1 lp/mm 62% 2 lp/mm 33% 3 lp/mm 17% 3.4 lp/mm 13%¹ 3.5 lp/mm 12% (Nyquist) | 1 lp/mm 60% 2 lp/mm 30% 3 lp/mm 15% 3.4 lp/mm 13%† 3.5 lp/mm 12% (Nyquist) | 1 lp/mm 64% 2 lp/mm 32% 3 lp/mm 17% 3.4 lp/mm 13% 3.5 lp/mm 12% (Nyquist) | Equivalent | | Detective Quantum Efficiency (DQE) | DQE at 1 μGy - 1 lp/mm 50% 2 lp/mm 40% 3 lp/mm 23% 3.4 lp/mm 17%† 3.5 lp/mm 15% | DQE at 2.5 μGy 0.05 lp/mm 66% 1 lp/mm 51% 2 lp/mm 39% 3 lp/mm 22% 3.4 lp/mm 15%* 3.5 lp/mm 13%* | DQE at 1 μGy 0.05 lp/mm 65% 1 lp/mm 51% 2 lp/mm 42% 3 lp/mm 25% 3.4 lp/mm 18% | Equivalent | | Image Processing | Philips Thoravision (510(k) Number: K931071) | XD-S Eleva Workstation (previously "XD-S Direct Workstation/Package") (510(k) Number: K063781) | XD-S Eleva Workstation (previously "XD-S Direct Workstation/Package") (510(k) Number: K063781) | Identical | {3}------------------------------------------------ ・ : {4}------------------------------------------------ | Linear approximation to facilitate direct comparison. · ﺮ ﺩ . {5}------------------------------------------------ | | Predicate Device: Pixium 4600 Detector | Predicate Device: FD-W17 | New Device: Pixium 4343RC | Discussion | |--------------------------|----------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------| | Grid line suppression | Mechanical Grid Oscillation | Mechanical Grid Oscillation or Image Pre-Processing ("Grid Suppression") | Mechanical Grid Oscillation or Image Pre-Processing ("Grid Suppression") | Identical | Note: Table entries identified by grey cell shading are stated for reference purposes only. ## Description of Clinical Testing 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. ## Guidance Discussion All applicable and identified requirements provided in the used guidance documents - Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging . Devices - Format for Traditional and Abbreviated 510(k) . - Pediatric Information for X-ray Imaging Device Premarket Notifications, . Drafi - Guidance for the Content of Premarket Submissions for Software Contained . in Medical Devices - . Refuse to Accept Policy for 510(k)s demonstrate substantial equivalence. The modified device conforms to the following US recognized consensus standards for safety for medical devices: - . ANSI/AAMI ES 60601-1:2005/(R)2012 and C1:2009/(R)2012 - Medical electrical equipment—Part 1: General requirements for basic safety and essential performance 2 - IEC 60601-1-2 Edition 3:2007-03 Medical Electrical Equipment Part 1-2: . General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests+ * 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) \$\left(smh.7\right)\$ (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 - Page 4-1 of 1 -

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