(137 days)
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 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.
Here's an analysis of the acceptance criteria and study information for the Philips Pixium 4343RC, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the Philips Pixium 4343RC primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and a clinical concurrence study. It does not explicitly list "acceptance criteria" in a quantitative performance metric sense (e.g., target accuracy, sensitivity/specificity thresholds for diagnostic tasks). Instead, the acceptance criteria are implicitly that the new device performs at least as well as, or is equivalent to, the predicate devices across various technical and clinical aspects.
The table below summarizes the key technical characteristics and performances compared between the new device and its predicates, which serve as the implicit "acceptance criteria" for demonstrating equivalence.
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Philips Pixium 4343RC) | Discussion/Outcome (as per document) |
|---|---|---|
| Indications for Use: | ||
| Acquire digital radiographic images for routine radiography, including specialist areas (intensive care, trauma, pediatric work), excluding fluoroscopy, angiography, and mammography. (Aligned with FD-W17) | Acquire digital radiographic images for routine radiography, including specialist areas (intensive care, trauma, pediatric work), excluding fluoroscopy, angiography, and mammography. | Identical / Equivalent |
| X-Ray Absorber: CsI Scintillator (Both Predicates) | CsI Scintillator | Identical |
| Installation type: Stationary, permanently installed (Pixium 4600) | Stationary, permanently installed | Identical |
| Readout Mechanism: Switching Diode (Pixium 4600) / Thin Film Transistor (FD-W17) | Thin Film Transistor | Equivalent |
| MTF (Modulation Transfer Function): | ||
| 1 lp/mm: 62% (Pixium 4600), 60% (FD-W17) | 1 lp/mm: 64% | Equivalent |
| 2 lp/mm: 33% (Pixium 4600), 30% (FD-W17) | 2 lp/mm: 32% | Equivalent |
| 3 lp/mm: 17% (Pixium 4600), 15% (FD-W17) | 3 lp/mm: 17% | Equivalent |
| 3.4 lp/mm: 13% (Both Predicates) | 3.4 lp/mm: 13% | Equivalent |
| 3.5 lp/mm (Nyquist): 12% (Both Predicates) | 3.5 lp/mm (Nyquist): 12% | Equivalent |
| DQE (Detective Quantum Efficiency) at 1 μGy: | ||
| 1 lp/mm: 50% (Pixium 4600), 51% (FD-W17 at 2.5 µGy) | 1 lp/mm: 51% (at 1 µGy) | Equivalent |
| 2 lp/mm: 40% (Pixium 4600), 39% (FD-W17 at 2.5 µGy) | 2 lp/mm: 42% (at 1 µGy) | Equivalent |
| 3 lp/mm: 23% (Pixium 4600), 22% (FD-W17 at 2.5 µGy) | 3 lp/mm: 25% (at 1 µGy) | Equivalent |
| 3.4 lp/mm: 17% (Pixium 4600), 15% (FD-W17 at 2.5 µGy) | 3.4 lp/mm: 18% (at 1 µGy) | Equivalent |
| 3.5 lp/mm (Nyquist): 15% (Pixium 4600), 13% (FD-W17 at 2.5 µGy) | 3.5 lp/mm: Not explicitly stated, but implies high similarity to 3.4 lp/mm. | Equivalent |
| Image Processing: Philips Thoravision (Pixium 4600) / XD-S Eleva Workstation (FD-W17) | XD-S Eleva Workstation | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "concurrence study" was conducted but does not specify the sample size (number of images or cases) used for the test set.
The data provenance is not explicitly stated as country of origin, nor is it explicitly labeled as retrospective or prospective. Given it's a "concurrence study" for regulatory submission, it is typically a controlled study, which could be either.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the concurrence study. It only states that the study confirmed the device "provides images of equivalent diagnostic capability to the predicate radiographic system." This implies expert assessment, but details are missing.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used in the concurrence study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe an MRMC comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance. The study described is a "concurrence study" focused on the diagnostic capability of the new device's images being equivalent to a predicate, not on human-AI collaboration.
6. Standalone (Algorithm Only) Performance Study
The device itself is a Solid State X-ray Imaging Device (a digital detector), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance study, often associated with AI software, is not applicable in this context. The entire device, including its hardware and integrated image processing software (XD-S Eleva Workstation), is being evaluated as a system that produces diagnostic images.
7. Type of Ground Truth Used
The document implies that the ground truth for the concurrence study was based on the diagnostic capability of images from the predicate device. The study's goal was to show that the new device "provides images of equivalent diagnostic capability to the predicate radiographic system." This means the predicate device's images (presumably deemed diagnostically acceptable by current clinical practice) served as the reference for equivalence. It does not explicitly mention pathology or outcomes data as direct ground truth for the study itself, but rather clinical equivalence.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is understandable as the Pixium 4343RC is a hardware device (X-ray imager) with associated image processing software. While the image processing software itself might have been "trained" or optimized during its development, this submission focuses on the performance of the integrated hardware and software system, comparing it to predicate devices, not detailing the training of specific algorithms within the image processor.
9. How the Ground Truth for the Training Set Was Established
Since no training set and associated ground truth are explicitly mentioned for this device's submission, this information is not provided in the document.
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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
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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'.
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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 4600Detector | Predicate Device:FD-W17 | New Device: Pixium4343RC | Discussion | |
|---|---|---|---|---|
| 510(k) Number | K982795 (PhilipsBucky Vision alsoknown as theDigital Diagnost) | K090625 (PhilipsWireless PortableDetector FD-W17) | N/A | N/A |
| Description | Detector, part ofPhilips DigitalDiagnost(previously"Bucky Vision") | Detector, part ofPhilips DigitalDiagnost (previously"Bucky Vision") | Detector, part ofPhilips DigitalDiagnost (previously"Bucky Vision") | Identical |
| Device Type | Solid State X-RayImager (MQB) | Solid State X-RayImager (MQB) | Solid State X-RayImager (MQB) | Identical |
| 510(k) Owner | Philips MedicalSystems DMC,Hamburg,Germany | Philips MedicalSystems DMC,Hamburg, Germany | Philips MedicalSystems DMC,Hamburg, Germany | Identical |
| Indications forUse | The Philips BuckyVision is intendedfor use in generalradiographicexaminations andapplicationswhereverconventionalscreen-filmsystems may beused (excludingfluoroscopy,angiography, andmammography) | As a part of aradiographic system,the WirelessPortable DetectorFD-W17 is intendedto acquire digitalradiographic images.The WirelessPortable DetectorFD-W17 is suitablefor all routineradiography exams,including specialistareas like intensivecare, trauma, orpediatric work | As a part of aradiographic system,the Pixium 4343RC isintended to acquiredigital radiographicimages. The Pixium4343RC is suitable forall routine radiographyexams, includingspecialist areas likeintensive care, trauma,or pediatric work,excluding fluoroscopy,angiography andmammography. | Identical /Equivalent |
| Predicate Device:Pixium 4600Detector | Predicate Device:FD-W17 | New Device: Pixium4343RC | Discussion | |
| excludingfluoroscopy,angiography andmammography. | ||||
| X-RayAbsorber | CsI Scintillator | CsI Scintillator | CsI Scintillator | Identical |
| Installationtype | Stationary,permanentlyinstalled | Portable | Stationary,permanently installed | Identical |
| ReadoutMechanism | Switching Diode | Thin Film Transistor | Thin Film Transistor | Equivalent |
| Detector Size | 533 x 488 x 45.5mm³ | 489 x 466 x 25 mm³ | 500 x 490 x 45.5 mm³ | Equivalent |
| DetectorWeight | 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 Imageto Rim | 27.5 mm | 28.2 mm | 34.9 mm | Equivalent |
| Pixel Size | 143 µm | 144 µm | 148 µm | Equivalent |
| NyquistFrequency: | 3.50 lp/mm | 3.47 lp/mm | 3.37 lp/mm | Equivalent |
| ADCDigitisation | 14 bit | 16 bit | 16 bit | Equivalent |
| Maximum X-ray Dose forLinearResponse | 30 µGy | 50 µGy | 50 µGy | Equivalent |
| MaximumUsable Dose | 60 µGy | 75 µGy | 85 µGy | Equivalent |
| Number ofModes | 5 | 1 | 2 | Equivalent |
| ExposureWindowDurations | 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/oRadiographicGrid? | Yes | Yes | Yes | Identical |
| Maximum | 100 Gy | 100 Gy | 100 Gy | Identical |
| Predicate Device:Pixium 4600Detector | Predicate Device:FD-W17 | New Device: Pixium4343RC | Discussion | |
| Lifetime Dose | 4 h | 2 h | 4 h | Identical |
| Warm-upDuration beforeCalibration | ||||
| DigitalSubtractionAngiography(DSA) | None (exemptfrom intended use) | None (exempt fromintended use) | None (exempt fromintended use) | Identical |
| PositioningMode | None | None | None | Identical |
| Stitching Mode(Implementedin Detector) | None | None | None | Identical |
| Binning | None (1 x 1) | None (1 x 1) | None (1 x 1) | Identical |
| Framespeed:DynamicImaging –Pulsed | None | None | None | Identical |
| Data Interfaceto Workstation | Taxi | 100 Mbit/s Ethernet | 100 Mbit/s Ethernet | Equivalent |
| PowerConsumption | 18 W | 10 W | 20.4 W | Equivalent |
| ModulationTransferFunction(MTF) | 1 lp/mm 62%2 lp/mm 33%3 lp/mm 17%3.4 lp/mm 13%¹3.5 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 |
| DetectiveQuantumEfficiency(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 μGy0.05 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 μGy0.05 lp/mm 65%1 lp/mm 51%2 lp/mm 42%3 lp/mm 25%3.4 lp/mm 18% | Equivalent |
| ImageProcessing | PhilipsThoravision(510(k) Number:K931071) | XD-S ElevaWorkstation(previously "XD-SDirectWorkstation/Package")(510(k) Number:K063781) | XD-S ElevaWorkstation(previously "XD-SDirectWorkstation/Package")(510(k) Number:K063781) | Identical |
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・
:
{4}------------------------------------------------
| Linear approximation to facilitate direct comparison.
·
ﺮ ﺩ
.
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| Predicate Device:Pixium 4600Detector | Predicate Device:FD-W17 | New Device: Pixium4343RC | Discussion | |
|---|---|---|---|---|
| Grid linesuppression | Mechanical GridOscillation | Mechanical GridOscillation or ImagePre-Processing("GridSuppression") | Mechanical GridOscillation or ImagePre-Processing ("GridSuppression") | 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
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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.
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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.
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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
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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
- Page 4-1 of 1 -
§ 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.