DigitalDiagnost C50

K201725 · Philips Healthcare (Suzhou) Co., Lit. · KPR · Jul 10, 2020 · Radiology

Device Facts

• Record ID: K201725
• Device Name: DigitalDiagnost C50
• Applicant: Philips Healthcare (Suzhou) Co., Lit.
• Product Code: KPR · Radiology
• Decision Date: Jul 10, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/ trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

Device Story

DigitalDiagnost C50 is a stationary digital radiography (DR) system for human anatomy imaging. Components include ceiling-suspended X-ray tube, wall stand, patient table with floating top, high-voltage generator, and acquisition/review workstation. Operated by clinicians/technicians in clinical settings. System captures X-ray signals via fixed or wireless digital detectors; processes data using UNIQUE 2 software; displays images for review; supports DICOM network transfer. Facilitates diagnostic examinations; aids clinical decision-making through high-quality radiographic visualization.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including verification and validation of technical specifications, image quality, and compliance with international consensus standards (IEC 60601 series, ISO 14971, etc.) and FDA guidance for solid-state X-ray imaging devices.

Technological Characteristics

Stationary X-ray system; ceiling suspension; high-voltage generator (50/65kW); rotating anode X-ray tube (150kV, 0.6/1.2mm focal spot). Detectors: Pixium 4343RCE (fixed, CsI) and SkyPlate E (wireless, CsI). Connectivity: DICOM 3.0. Software: UNIQUE 2 image processing, Windows 10 embedded OS. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 60601-1-6, IEC 62304, IEC 62366-1, ISO 14971.

Indications for Use

Indicated for generating radiographic images of human anatomy in patients sitting, standing, or lying (prone/supine). For use by qualified/trained doctors or technicians. Not for mammographic applications.

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

• DigitalDiagnost C50 (K163410)

Reference Devices

• MobileDiagnost WDR 2.2 (K191813)
• Philips Eleva Workspot with SkyFlow (K153318)
• DigitalDiagnost C90 (K182973)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Healthcare (Suzhou) Co., Lit. % Claire Zhang Advanced Regulatory Engineer No. 258, ZhongYuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA

## Re: K201725

Trade/Device Name: DigitalDiagnost C50 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: June 8, 2020 Received: June 23, 2020

Dear Claire Zhang:

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 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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 of medical device-related adverse events) (21 CFR 803) for

July 10, 2020

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201725

Device Name DigitalDiagnost C50

#### Indications for Use (Describe)

The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/ trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

## SPECIAL 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

| Date Prepared: | June 08, 2020 | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.<br>No. 258, Zhong Yuan Road, Suzhou Industrial Park, 215024<br>Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA<br>Establishment Registration Number: 3009529630 | |
| Contact Person: | Claire Zhang<br>Advanced Regulatory Engineer<br>Phone: [phone] (cell: [phone])<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Device Name: | DigitalDiagnost C50 | |
| Classification: | Classification Name<br>Classification Regulation:<br>Classification Panel:<br>Device Class:<br>Product code: | Stationary X-Ray System<br>21CFR §892.1680<br>Radiology<br>Class II<br>KPR (System, X-Ray, Stationary) |
| Predicate Device: | Trade Name:<br>Manufacturer:<br>510(k) Clearance:<br>Classification Regulation:<br>Classification Name:<br>Classification Panel:<br>Device Class:<br>Product Code | DigitalDiagnost C50<br>Philips Healthcare (Suzhou) Co.,<br>Ltd.<br>K163410-January 4, 2017<br>21 CFR, Part 892.1680<br>Stationary X-Ray System<br>Radiology<br>Class II<br>KPR |
| Reference Device 1: | Trade Name:<br>Manufacturer:<br>510(k) Clearance:<br>Classification Regulation:<br>Classification Name:<br>Classification Panel:<br>Device Class:<br>Product Code | MobileDiagnost WDR 2.2<br>SEDECAL SA<br>K191813- August 2, 2019<br>21CFR 892.1720<br>Mobile x-ray system<br>Radiology<br>Class II<br>IZL, MQB |
| Reference Device 2: | Trade Name: | Philips Eleva Workspot with<br>SkyFlow |
| | Manufacturer: | Philips Medical Systems<br>DMC GmbH |
| | 510(k) Clearance: | K153318- December 22, 2015 |
| | Classification Regulation: | 21 CFR 892.1680 |
| | Classification Name: | Stationary X-Ray System |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code | MQB, LLZ |
| Reference Device 3: | Trade Name: | DigitalDiagnost C90 |
| | Manufacturer: | Philips Medical Systems<br>DMC GmbH |
| | 510(k) Clearance: | K182973- January 11, 2019 |
| | Classification Regulation: | 21CFR 892.1680 |
| | Classification Name: | Stationary X-Ray System |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code | MQB, KPR, LLZ |
| Device description: | The DigitalDiagnost C50 Digital Radiography System<br>(DigitalDiagnost C50) is a flexible digital radiography (DR)<br>system that is designed to provide fast and smooth<br>radiography examinations of sitting, standing or lying<br>patients.<br><br>The DigitalDiagnost C50 consist of the following<br>components: ceiling suspension with X-ray assembly, wall<br>stand with detector carrier, patient table with detector carrier<br>and floating table top, high voltage generator, and an<br>acquisition and reviewing workstation for post-processing,<br>storage and viewing of images. Images may be transferred via<br>a DICOM network for printing, storage and detailed review. | |
| Indications for use: | The DigitalDiagnost C50 is intended for use in generating<br>radiographic images of human anatomy by qualified/trained<br>doctor or technician. Applications can be performed with the<br>patient sitting, standing, or lying in the prone or supine<br>position. This device is not intended for mammographic<br>applications. | |
| Fundamental scientific<br>technology: | The fundamental scientific technology utilized in the<br>DigitalDiagnost C50 and the currently marketed and | |

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predicate DigitalDiagnost C50 (K163410, January 4, 2017) is equivalent with regards to the functionality of the following components: integrated tube assembly, patient table with a floating table top, high-voltage generator, dual-focus rotation anode X-Ray tube, manual beam limiting device, digital detector, wall stand and workstation for images postprocessing, storage and viewing (See Table 1 comparing the DigitalDiagnost C50 to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) provided below).

The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the DigitalDiagnost C50 when compared to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017).

The wireless portable detector of the DigitalDiagnost C50 is identical to the wireless portable detector (SkyPlate E) of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813-August 2, 2019) manufactured by SEDECAL SA. Therefore, both the wireless portable detector (Skyplate E) of the DigitalDiagnost C50 and the currently marketed and reference device 1, MobileDiagnost WDR 2.2 employ identical fundamental scientific technology.

The DigitalDiagnost C50 and the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019) manufactured by Philips Medical Systems DMC GmbH are provided with identical, fixed RAD detector (Pixium 4343RCE), UNIQUE 2 Post Processing software, embedded Windows 10 operating system. Therefore, DigitalDiagnost C50 and the currently marketed and reference device 3, DigitalDiagnost C90 employ identical fundamental scientific technology in fixed RAD detector (Pixium 4343RCE), UNIQUE 2 Post Processing software, embedded Windows 10 operating system.

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| Table 1<br>Comparison of Technological Characteristics of Currently marketed and Predicate DigitalDiagnost C50<br>versus the DigitalDiagnost C50 | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Predicate Device:<br>DigitalDiagnost C50<br>(K163410, January 4, 2017) | Device:<br>DigitalDiagnost C50 | Comment |
| Basic information | | | |
| Product Code | KPR | Identical | No difference; thus,<br>demonstrating SE. |
| Regulation No. | 21 CFR 892.1680 | Identical | No difference; thus,<br>demonstrating SE. |
| Device Class | II | Identical | No difference: thus.<br>demonstrating SE. |
| Electrical<br>Requirement | Input voltage: 3-phase,<br>200/208/240/380/400/415/44<br>0/480/500Vac;<br>Frequency:50/60Hz;<br>Current:<br>Short term: 112A (with<br>generator M-CABINET<br>CXA<br>50kW), 134A (M-CABINET<br>CXA 65kW);<br>Long term: 10A. | Identical | No difference; thus,<br>demonstrating SE. |
| Design characteristic | | | |
| X-ray Tube | RO 1750 ROT 380 & SRO<br>33100 ROT 380 | Identical | No difference; thus,<br>demonstrating SE. |
| Max Tube<br>Voltage | 150 kV | Identical | No difference; thus,<br>demonstrating SE. |
| Focal Spot Size | 0.6mm/1.2mm | Identical | No difference: thus.<br>demonstrating SE. |
| Tube Max<br>power | 50KW/100KW<br>(250W equivalent anode<br>input power) | Identical | No difference; thus,<br>demonstrating SE. |
| Anode Type | Rotation | Identical | No difference; thus,<br>demonstrating SE. |
| Generator | Philips Healthcare<br>(Suzhou),<br>M-CABINET CXA Pro<br>50kW,<br>M-CABINET CXA Pro<br>65kW | Identical | No difference; thus,<br>demonstrating SE. |
| Max Power | 50KW/65KW | Identical | No difference; thus,<br>demonstrating SE. |
| KV range | 40-150 | Identical | No difference; thus,<br>demonstrating SE. |
| Milli ampere sec<br>(mAs) product | 0.4 mAs-600 mAs (with<br>AEC control) | Identical | No difference; thus,<br>demonstrating SE. |
| Collimator | | | |
| Operation Mode | Manual collimation | Identical | No difference; thus,<br>demonstrating SE. |
| Shape of Beam | Rectangular | Identical | No difference; thus,<br>demonstrating SE. |
| Detector | | | |
| Type | Digital Detector | Identical | No difference; thus,<br>Demonstrating SE. |
| | Fixed RAD Detector | | |
| | Wireless Static Detector | | |
| Fixed RAD<br>Detector | Pixium 4343RG | Pixium 4343RCE<br>(Note: this detector is<br>identical to fixed RAD<br>detector of the currently<br>marketed and Reference<br>Device 3, DigitalDiagnost<br>C90 cleared under<br>K182973). | The difference between<br>4343RCE and 4343RG is<br>scintillator material and other<br>minor differences of image<br>area and image matrix as<br>compared in this table. The<br>differences don't affect the<br>safety or effectiveness.<br>And the fixed RAD detector<br>Pixium 4343RCE of the<br>DigitalDiagnost C50 is<br>identical to the fixed RAD<br>detector of the currently<br>marketed and Reference<br>Device 3, DigitalDiagnost<br>C90(K182973- January 11,<br>2019, Philips Medical Systems<br>DMC).<br>Thus, demonstrating SE |
| Wireless Static<br>Detector | Varian PaxScan4336W | SkyPlate E (Trixell<br>3543DR)<br>(Note: this detector is<br>identical to the Skyplate E<br>Detector of the currently<br>marketed and reference<br>device 1, MobileDiagnost<br>WDR 2.2 cleared under<br>K191813). | The Skyplate E Detector of the<br>proposed DigitalDiagnost C50<br>is identical to the Skyplate E<br>Detector of the currently<br>marketed and Reference<br>Device 1, MobileDiagnost<br>WDR 2.2 (K191813- August 2,<br>2019).<br>Thus, demonstrating SE |
| X-ray<br>Scintillator<br>Material | GdOS (Fixed: Pixium<br>4343RG) | Cesium Iodide (Fixed:<br>Pixium 4343RCE. )<br>Note: Pixium<br>4343RCE is identical<br>to fixed RAD detector<br>of the currently<br>marketed and<br>Reference Device 3,<br>DigitalDiagnost C90<br>cleared under<br>K182973. | The fixed RAD detector of the<br>proposed DigitalDiagnost C50<br>and currently marketed and<br>Reference Device 3,<br>DigitalDiagnost<br>C90(K182973- January 11,<br>2019, Philips Medical Systems<br>DMC) are both fabricated<br>from identical Cesium Iodide<br>material , thus demonstrating<br>SE. |
| | GdOS<br>(Wireless Varian<br>PaxScan4336W) | Cesium Iodide<br>(Wireless SkyPlate E) | The Wireless Detector of the<br>proposed DigitalDiagnost C50<br>and the currently marketed and<br>Reference Device 1,<br>MobileDiagnost WDR 2.2<br>(K191813- August 2, 2019) are<br>both fabricated from identical<br>Cesium Iodide material, thus<br>demonstrating SE. |
| Image Area | 42.5cm x 42.5cm<br>(Fixed: Pixium 4343RG)42.7 cm x 34.4 cm<br>(Wireless: Varian<br>PaxScan4336W) | 42.03cm x 42.54cm<br>(Fixed: Pixium<br>4343RCE)34.5 cm x 42.5cm<br>(Wireless: SkyPlate E) | The image area of the<br>DigitalDiagnost C50,<br>provided with fixed RAD<br>detector is identical to the<br>image area of the Fixed RAD<br>Detector of the currently<br>marketed and Reference<br>Device 3, DigitalDiagnost<br>C90(K182973- January 11,<br>2019, Philips Medical Systems<br>DMC), thus demonstrating<br>substantial equivalence<br>The image area of the proposed<br>Wireless Detector SkyPlate E<br>is identical to the Wireless<br>Detector SkyPlate E of the<br>currently marketed and<br>reference device 1,<br>MobileDiagnost WDR 2.2<br>(K191813- August 2, 2019,<br>Sedecal SA,). thus<br>demonstrating SE. |
| Image Matrix | 2,874 x 2,869<br>(Fixed: Pixium 4343RG)3,072 x 2,476<br>(Wireless: Varian<br>PaxScan4336W) | 2,874 x 2840<br>(Fixed: Pixium<br>4343RCE)2,156 x 2,653<br>(Wireless-SkyPlate E) | The image matrix of the<br>proposed DigitalDiagnost<br>C50, provided with fixed RAD<br>detector is similar to the image<br>matrix of the currently<br>marketed and Reference<br>Device 3, DigitalDiagnost<br>C90(K182973- January 11,<br>2019, Philips Medical Systems<br>DMC). thus demonstrating<br>substantial equivalence<br>The image matrix of the<br>proposed DigtialDiagnost C50<br>provided with wireless detector<br>SkyPlate E is similar to the<br>currently marketed and<br>Reference Device 1,<br>MobileDiagnost WDR 2.2<br>(K191813- August 2, 2019,<br>Sedecal SA). Infinitesimal<br>change in the image size (X-<br>ray field) does not impact<br>clinical Image Quality.<br>Therefore, they are equivalent<br>and there is no impact on the<br>safety and effectiveness of the<br>device; thus, demonstrating<br>SE. |
| Pixel Size | | | |
| | 148 μm (Fixed: Pixium 4343RG)<br><br>139 μm (Wireless: Varian PaxScan4336W) | • 148 μm (Fixed: Pixium 4343RCE)<br><br>• 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed <b>DigtialDiagnost C50</b> provided with fixed RAD detector is identical to the pixel size of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019,). thus demonstrating substantial equivalence.<br><br>The pixel size of the proposed <b>DigtialDiagnost C50</b> provided with wireless detector SkyPlate E is identical to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA), thus demonstrating SE. |
| Analog / Digital (A/D) conversion | 16 bits | Identical | No difference; thus, demonstrating SE.…