Who is the manufacturer of DuraDiagnost?

Philips Healthcare (Suzhou) Co., Ltd. filed the 510(k) submission for DuraDiagnost (K201640).

What is the FDA product code for DuraDiagnost?

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

What is the regulatory pathway for DuraDiagnost?

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

Who can help prepare an FDA 510(k) submission like DuraDiagnost?

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.

DuraDiagnost

K201640 · Philips Healthcare (Suzhou) Co., Ltd. · KPR · Jul 9, 2020 · Radiology

Device Facts

Record ID	K201640
Device Name	DuraDiagnost
Applicant	Philips Healthcare (Suzhou) Co., Ltd.
Product Code	KPR · Radiology
Decision Date	Jul 9, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1680
Device Class	Class 2

Intended Use

The DuraDiagnost 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

DuraDiagnost is a stationary digital radiography (DR) system for human anatomy imaging. Components include a tube column with X-ray assembly, wall stand, patient table with floating top, high-voltage generator, and acquisition/reviewing workstation. Operated by qualified doctors or technicians in clinical settings. The system captures X-ray signals via digital detectors (fixed or wireless), processes them using UNIQUE 2 software, and displays images for clinical review. Output is used for diagnostic radiographic examinations. Benefits include fast, smooth imaging workflows. The system supports DICOM network transfer for storage and printing.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance testing, including verification and validation of technical requirements, risk management, and compliance with international consensus standards (e.g., IEC 60601 series, ISO 14971).

Technological Characteristics

Stationary X-ray system; 50kW/65kW generator; dual-focus rotation anode X-ray tube (150kV max); digital detectors (Cesium Iodide scintillator); height-adjustable floating table; manual collimation. Connectivity: DICOM. 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). 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

DuraDiagnost (K141381)

Reference Devices

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

Related Devices

K141381 — DURADIAGNOST · Philips Healthcare (Suzhou) Co., Ltd. · Jun 12, 2014
K201725 — DigitalDiagnost C50 · Philips Healthcare (Suzhou) Co., Lit. · Jul 10, 2020
K190601 — MasteRad MX30 · Medicatech USA · Apr 25, 2019
K163410 — DigitalDiagnost C50 · Philips Healthcare (Suzhou) Co., Ltd. · Jan 4, 2017
K214012 — Straight Arm DDR · Konica Minolta Healthcare Americas, Inc. · Jan 12, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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., Ltd. % Ms. Mary Zhu Senior Regulatory Engineer No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 REPUBLIC OF CHINA July 9, 2020 ### Re: K201640 Trade/Device Name: DuraDiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: June 1, 2020 Received: June 16, 2020 Dear Ms. Zhu: 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201640 Device Name DuraDiagnost Indications for Use (Describe) The DuraDiagnost 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) | | |---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) number: K201640 # 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: Manufacturer: | June 01, 2020 Philips Healthcare (Suzhou) Co., Ltd. No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024 Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Establishment Registration Number: 3009529630 2nd manufacturing site: Philips Medical Systems Nederland B.V. Veenpluis 6, 5684PC Best, The Netherlands Establishment Registration Number: 3003768277 | | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Contact Person: | Mary Zhu Senior Regulatory Engineer Phone: +86-021-24128746(cell: +86-183-5113-2881) Fax: +86-512-68018677 E-mail: Mary.ZHU@philips.com | | | Device Name: Classification: | DuraDiagnost Classification Name: Stationary X-Ray System Classification Regulation: 21CFR §892.1680 Classification Panel: Radiology Device Class: Class II Primary product code: KPR (System, X-Ray, Stationary) Secondary code: MQB(21 CFR 892.1680) | | | Predicate Device: | Trade Name: DuraDiagnost Manufacturer: Philips Healthcare (Suzhou) Co., Ltd. 510(k) Clearance: K141381-June 12, 2014 Classification Regulation: 21 CFR, Part 892.1680 Classification Name: Stationary X-Ray System Classification Panel: Radiology Device Class: Class II Product Code: KPR, MQB | | | Reference Device 1: | Trade Name: MobileDiagnost WDR 2.2 Manufacturer: SEDECAL SA | | | | 510(k) Clearance: | K191813- August 2, 2019 | | | Classification Regulation: | 21CFR 892.1720 | | | Classification Name: | Mobile x-ray system | | | Classification Panel: | Radiology | | | Device Class: | Class II | | | Product Code | IZL, MQB | | Reference Device 2: | Trade Name: | Philips Eleva Workspot with SkyFlow | | | Manufacturer: | Philips Medical Systems 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 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 DuraDiagnost is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review. | | | Indications for use: | The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the | | {4}------------------------------------------------ Page 2 of 14 {5}------------------------------------------------ patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications. The fundamental scientific technology utilized in the Fundamental scientific technology: DuraDiagnost and the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) is equivalent with regards to the functionality of the following components: Integrated tube column, 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 post-processing, storage and viewing (See Table 1 comparing the DuraDiagnost to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014) 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 DuraDiagnost when compared to the currently marketed and predicate DuraDiagnost (K141381, June 12, 2014). > The wireless portable detector of the DuraDiagnost 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 DuraDiagnost and the currently marketed and reference device 1, MobileDiagnost WDR 2.2 employ identical fundamental scientific technology. > The DuraDiagnost 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 and embedded Windows 10 operating system. Therefore, DuraDiagnost and the currently marketed and reference {6}------------------------------------------------ device 3, DigitalDiagnost C90 employ identical fundamental scientific technology. | Table 1 | | | | |----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison of Technological Characteristics of Currently marketed and Predicate DuraDiagnost versus the DuraDiagnost | | | | | Feature | Predicate Device: DuraDiagnost (K141381) | Device: DuraDiagnost | Comment | | Basic information | | | | | Product Code | KPR & MQB | Identical | No difference; thus, demonstrating SE. | | Regulation No. | 21 CFR 892.1680 | Identical | No difference; thus, demonstrating SE. | | Device Class | II | Identical | No difference; thus, demonstrating SE. | | Electrical Requirement | Input voltage: 3- phase, 200/208/240/380/40 0/415/440/480/500V ac; Frequency:50/60Hz; Current: Short term: 112A (with generator M-CABINET CXA Pro 50kW), 134A (with generator M- CABINET CXA Pro 65kW), 160A (with generator M-CABINET CXA Pro 80kW); Long term: 10A. | Input voltage: 3- phase, 200/208/240/380/40 0/415/440/480/500V ac; Frequency:50/60Hz; Current: Short term: 112A (with generator M-CABINET CXA Pro 50kW), 134A (with generator M- CABINET CXA Pro 65kW), Long term: 10A. | Equivalent. The DuraDiagnost and the currently marketed and predicate DuraDiagnost are both provided with similar electrical requirements. Therefore, no impact on the safety or effectiveness of the device. Thus, demonstrating SE. | | Design characteristic | | | | | X-ray Tube | RO 1750 ROT 360 & SRO 33100 ROT 360 | Identical | No difference; thus, demonstrating SE. | | Max Tube Voltage | 150kV | Identical | No difference; thus, demonstrating SE. | | Focal Spot Size | 0.6mm/1.2mm | Identical | No difference; thus, demonstrating SE. | | Tube Max power | 50KW/100KW (250W equivalent anode input power) | Identical | No difference; thus, demonstrating SE. | | Anode Type | Rotation | Identical | No difference; thus, demonstrating SE. | | | | | | | Generator | Philips Healthcare (Suzhou), M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW, M-CABINET CXA Pro 80kW | Philips Healthcare (Suzhou), M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW, | Equivalent. DuraDiagnost and the currently marketed and predicate DuraDiagnost are both provided with 50KW/65KW generators. Thus, demonstrating SE. | | Max Power | 50KW/65KW/80KW | 50KW/65KW | | | KV range | 40-150 | Identical | No difference; thus, demonstrating SE. | | Milli ampere sec (mAs) product | 0.4 mAs-600 mAs (with AEC control) | Identical | No difference; thus, demonstrating SE. | | Collimator | | | | | Operation Mode | Manual collimation | Identical | No difference; thus, demonstrating SE. | | Shape of Beam | Rectangular | Identical | No difference: thus, demonstrating SE. | | Detector | | | | | Type | Digital Detector • Fixed RAD Detector • Wireless Static Detector | Identical | No difference; thus, Demonstrating SE. | | Fixed RAD Detector | Pixium 4343RG | Pixium 4343RCE (Note: this detector is identical to fixed RAD detector of the currently marketed and Reference Device 3, DigitalDiagnost C90 cleared under K182973). | The difference between 4343RCE and 4343RG is scintillator material and other minor differences of image area and image matrix as compared in this table. The differences don't affect the safety or effectiveness. And the fixed RAD detector Pixium 4343RCE of the DuraDiagnost is identical to the fixed RAD detector of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC). Thus, demonstrating SE | | Wireless Static Detector | • SkyPlate Large (Trixell 3543EZ) | • SkyPlate Large (Trixell 3543EZ) | The SkyPlate Large Detector of the DuraDiagnost is identical to the SkyPlate | {7}------------------------------------------------ {8}------------------------------------------------ | | | | ● | SkyPlate E (Trixell 3543DR) (Note: this detector is identical to the Skyplate E Detector of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 cleared under K191813). | Large Detector of the currently marketed and Predicate DuraDiagnost (K141381, SkyPlate E is additionally added dectector. There are minor differences between SkyPlate E and the Skyplate Large detector of image area, image matrix and pixel size as compared in this table. The minor differences don't affect the safety or effectiveness. And the Skyplate E Detector of DuraDiagnost is identical to the Skyplate E Detector of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019). Thus, demonstrating SE | |--------------------------------|--------------------------------------------------|------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | X-ray Scintillator Material | ● | GdOS (Fixed: Pixium 4343RG) | ● | Cesium Iodide (Fixed: Pixium 4343RCE. Pixium 4343RCE is identical to fixed RAD detector of the currently marketed and Reference Device 3, DigitalDiagnost C90 cleared under K182973 ) | The fixed RAD detector of the DuraDiagnost and currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC) are both fabricated from identical Cesium Iodide material , thus demonstrating SE. | | | ● | Cesium Iodide (Wireless: SkyPlate Large) | ● | Cesium Iodide (Wireless: SkyPlate Large and SkyPlate E) | The Wireless detector of the DuraDiagnost and the currently marketed and predicate DuraDiagnost are both fabricated from identical Cesium Iodide material, thus demonstrating SE. | | Image Area | ● | 42.5cm x 42.5cm (Fixed: Pixium 4343RG) | ● | 42.03cm x 42.54cm(Fixed: Pixium 4343RCE) | The image area of the DuraDiagnost, provided with fixed RAD detector is | | | 34.5cm x 42.1cm (Wireless: SkyPlate Large) | | 34.5cm x 42.1cm(Wireless: SkyPlate Large) | identical to the image area of the Fixed RAD Detector of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC), thus demonstrating substantial equivalence | | | | | 34.5cm x 42.5cm(Wireless: SkyPlate E) | | The image area of the proposed DuraDiagnost, provided with wireless detector SkyPlate Large is identical to the wireless detector SkyPlate Large of the currently marketed and Predicate DuraDiagnost (K141381). Thus, demonstrating SE. | | | | | | | The image area of the proposed Wireless Detector SkyPlate E is identical to the Wireless Detector SkyPlate E of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA,). thus demonstrating SE | | | Image Matrix | 2,874 x 2,869 (Fixed: Pixium 4343RG) | | 2,874 x 2840 (Fixed: Pixium 4343RCE) | The image matrix of the proposed DuraDiagnost Philips Medical Systems | | | | 2330 x 2846 (Wireless-SkyPlate Large) | | 2330 x 2846 (Wireless- SkyPlate Large) | DMC, provided with fixed RAD detector is identical to the image matrix of the | | {9}------------------------------------------------ {10}------------------------------------------------ | ● | 2156 x 2653 (Wireless- SkyPlate E) | currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019,). thus demonstrating substantial equivalence. | |---|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | The image matrix of the DuraDiagnost provided with the wireless SkyPlate Large Detector is identical to the wireless SkyPlate Large of the currently marketed predicate Device DuraDiagnost, (K141381). Thus demonstrating SE. | | | | The image matrix of the DuraDiagnost provided with wireless detector SkyPlate E is similar to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA). Infinitesimal change in the image size (X-ray field) does not impact clinical Image Quality. Therefore, they are equivalent and there is no impact on the safety and effectiveness of the device; thus demonstrating SE. | {11}------------------------------------------------ | Pixel Size | • 148 μm (Fixed: Pixium 4343RG) • 148 μm(Wireless-SkyPlate Large) | • 148 μm (Fixed: Pixium 4343RCE) • 148 μm(Wireless-SkyPlate Large) • 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DuraDiagnost Philips Medical Systems DMC, 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. The pixel size of the DuraDiagnost provided with the wireless SkyPlate Large Detector is identical to the wireless SkyPlate Large of the currently marketed predicate Device DuraDiagnost, (K141381). Thus demonstrating SE. The pixel size of the DuraDiagnost 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. | | Table | | | | | Table type | Fixed and Height adjustment | Height adjustment | The DuraDiagnost is provided with height adjustment table that is also provided with the currently marketed and predicate…