The PLX5200A is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. It is not intended for mammography.

Device Description

The proposed device is a mobile x-ray system, it uses digital techniques for image capture, display and manipulation and the mobile design allows it to operate on mains or battery power and to be driven or pushed by an operator to various locations within a building or facility. It is commonly used for bedside imaging. This system consists of a mobile base unit, combined X-ray tube assembly, collimator, frame, X-ray flat panel detector, and image processing system.

AI/ML Overview

This device is a Diagnostic X-ray System, which is a hardware device. The provided text indicates that no clinical study was included in this submission. Therefore, there is no acceptance criteria or study data for device performance as requested for AI/software devices.

However, the submission does mention various performance data related to the hardware itself, which are not based on clinical efficacy or diagnostic accuracy. These include:

Electrical safety and electromagnetic compatibility (EMC): The system complies with IEC 60601-1:2005+A1:2012 / ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009, IEC 62471 standard for safety, and IEC 60601-1-2: 2014 standard for EMC. Radio frequency (RF) wireless coexistence of equipment testing was performed according to IEEE ANSI C63.27-2017.
Software Verification and Validation: The Embedded software and the workstation software were considered a "Moderate" level of concern and were verified and validated according to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." They comply with FDA recognized standard IEC 62304.
Cybersecurity: Documentation was provided according to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
DICOM: DICOM declaration was provided according to FDA recognized standard NEMA PS 3.1 - 3.20 (2016).
Usability Testing: Usability validation was performed and complies with FDA recognized standard IEC 60601-1-6 Edition 3.1 and EC 62366-1 Edition 1.0.
Risk Management: Activities were performed and documented according to FDA recognized standard ISO 14971 Second edition 2007-03-01.
Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including Cytotoxicity, Skin Sensitization, and Skin Irritation for the x-ray flat panel detector.

Since this is a hardware device clearance, and not an AI/software as a medical device (SaMD) or an AI-powered diagnostic device, the typical acceptance criteria and study design elements requested (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable or provided in this 510(k) summary.

Summary

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August 25, 2021

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.

Nanjing Perlove Medical Equipment Co., Ltd. % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai, 200071 CHINA

Re: K212134

Trade/Device Name: Diagnostic X-ray System/PLX5200A Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL. MOB Dated: June 15, 2021 Received: July 8, 2021

Dear Stuart Situ:

We have reviewed vour 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

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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 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,

Laurel M.

Burk -S

Digitally signed by Laurel M. Burk -S Date: 2021.08.25 09:52:14 -04'00'

、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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212134

Device Name Diagnostic X-ray System PLX5200A

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K212134

l Submitter

Nanjing Perlove Medical Equipment Co., Ltd. No.97&99, Wangxi Road, Jiangning District, Nanjing 211100, Jiangsu, China

Contact person:

Lu Fengfang Position: QC Manager Tel.: +86-025-68571666 E-mail: ce@perlove.com.cn Preparation date: Aug 10, 2021

II Proposed Device

Trade Name of Device:	Diagnostic X-ray System PLX5200A
Models:	PLX5200A
Regulation name:	Mobile X-Ray System
Regulation Number:	21 CFR 892.1720
Regulatory Class:	Class II
Product code:	IZL, MQB,
Review Panel	Radiology

III Predicate Devices

510(k) Number: K192011 a. Product Code: IZL, MQB Classification: 21 CFR 892.1720 Trade/Device Name: PhoeniX Manufacturer: SEDECAL SA Regulation Name: Mobile x-ray system Regulatory Class: Class II
510(k) Number: K201340 b. Product Code: IZL, MQB Classification: 21 CFR 892.1720 Trade/Device Name: AQUILA 320 D / AQUILA 320 S Manufacturer: VMI Tecnologias LTDA

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Regulation Name: Mobile x-ray system Regulatory Class: Class II

IV Reference Devices

510(k) Number: K150929 a. Product Code: MQB Regulation Name: Stationary x-ray system Regulatory Class: II Classification: 21 CFR 892.1680 Trade/Device Name: CareView 1500Cw X-Ray Flat Panel Detectors Manufacturer: CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
510(k) Number: K201004 b. Product Code: MQB Regulation Name: Stationary x-ray system Regulatory Class: Class II Classification: 21 CFR 892.1680 Trade Name: Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI Manufacturer: IRay Technology Taicang Ltd.

V Device description

Image /page/4/Figure/7 description: The image shows a mobile X-ray machine with several labeled components. The X-ray tube assembly and collimator are located at the top right of the machine. The image processing system is labeled on the left side of the machine, and the detector is located at the bottom left.

Figure V.1 Picture Illustration of PLX5200A

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Principles of Operation

X-rays are produced by the x-ray tube (an evacuated tube with an anode and a cathode) when a stream of electrons, accelerated to high velocities by a high-voltage, collides with the tube's target anode. Collimator confines the primary beam to the approximate size and shape that will cover only the area of diagnostic interest. The device is equipped with wireless x-ray flat panel detectors, which use a scintillator material to convert x-rays to visible light. An array of photodiodes on the scintillator layer absorbs the light and translates it into a signal for digital display.

PLX5200A is used for moving to a ward, an operation room, etc., and photographing the patient who is not suitable for moving.

PLX5200Ais configured with a 150kHu x-ray tube, a manual collimator, and small, light, wireless, easy handling portable DR detectors: CareView 1500Cw, and Mars1417V-TSI (both are FDA cleared) with capacity of wireless image capture and transmission technology. The wheeled image process system integrates the touch screen image acquisition computer with workstation software installed, and 50kw high frequency generator with micro-processor controls.

Software

The software of the Mobile Digital Radiography System includes an embedded software and a workstation software. The embedded software in the diagnostic system intended to control X-rays generation for examination of various anatomical regions. The workstation software is installed in the computer or tablet to complete the image data acquisition, image display, image processing, film printing, reporting, image transmission and other clinical work, such as registering patients' information, acquiring images, viewing images, writing and printing diagnostic report, DICOM file sending, DICOM film printing, database backup and restore, etc, which provide an effective means to manage medical image information for hospitals.

The level concern of the software of this device is Moderate.

VI Indication for use

The PLX5200A Mobile X-ray system is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions.

It is not intended for mammography.

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VII Comparison of technological characteristics with the predicate devices

The comparison between the overall specifications of the predicate devices and the proposed device (PLX5200A) is shown in Table 1. Any differences between the predicate and subject devices have no impact on safety or effectiveness of the subject devices and do not raise any potential safety risks.

Item	Proposed device	Predicate device 1(K192011)	Predicate device 2(K201340)	Discussion
Model name	PLX5200A	Phoenix	AQUILA 320 D / AQUILA320 S	-
ProductCode	IZL, MQB,	IZL, MQB	IZL, MQB	same
RegulationNo.	21 CFR 892.1720	21 CFR 892.1720	21 CFR 892.1720	same
Class	Class II	Class II	Class II	same
Indication foruse	The PLX 5200A Mobile X-ray system is intended foruse by a qualified/traineddoctor or technologist onboth adult and pediatricpatients for taking diagnosticradiographic exposures ofthe skull, spinal column,chest, abdomen, extremities,and other body parts.Applications can beperformed with patientsitting, standing or lying inthe prone or supinepositions.It is not intended formammography.	Intended for use by aqualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull,spinal column, chest,abdomen, extremities, andother body parts.Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.Not for mammography	Intended for use by aqualified/trained doctor ortechnician on both adultand pediatric subjects fortaking diagnosticradiographic exposuresof the skull, spinalcolumn, chest, abdomen,extremities, and otherbody parts. Applicationscan be performed withthe patient sitting,standing, or lying in theprone or supine position.Not for mammography	same
X-raygeneratorrating	50 kW	20 kW, 32 kW, 40 kW and50 kW.	35.2 kW only
				Same withPhoenix'smax rating.
X-ray voltagerange	40-150kV in 1 kV steps	From 40 kV to 150 kV in 1kV steps	From 40 to 125 kV in 1kV steps	same withPhoenix.
mARange	10~500mA	From 10 mA to 630 mA / 640mA /650 mA.	From 20 to 320 mA	similar
X-ray Tube	0.6/1.2, 150kv max;	E78860.7/1.3, 150kv max.XRR-3331:0.6/1.2, 150kv max	Unknown	SimilarThe samewith one ofPhoenix'stube.
Collimator	X5300:Manually, with addedfiltration 1.0mmAl/2.0mmAl;Inherent filtration: 1.5mmAl	Ralco R108F (Two versions,see details in PHOTOS itemin K192011 summary.)Manually.Parameters are unknown	Choice of ModelsLeadmec Collimator –LDM206Ralco Collimator - R104Ralco Collimator –R104/ARalco Collimator - R108SM Collimator – 38AParameters are unknownAll collimators meet theUS PerformanceStandard	Different
Collimatoroperationmethod	Manually adjustablecollimator	Manually	Unknown	Same withPhoenix.
Pixel pitch	CareView 1500Cw: 154 µmMars1417V-TSI: 150 µm	125um	Pixel pitches from 120 to154µm	similar
Effectivereceptionfield	14 in. x 17 in;	17 in. x 17 in;14 in. x 17 in;Or 11in×14in;	43x43cm, 35x43cm or24x30cm	Same withPhoenix'sone option.
Spatialresolution	Min 3.3lp/mm;	unknown	Min 3.3lp/mm;	Same withAQUILA320 D /AQUILA320 S
Software	PLX5200 workstationsoftware5200 Embedded Software	Canon control softwareCXDI-NE	DROC Software forCareray Detectors,(K201058 and others)ECONSOLE Software forDRTECH Detectors.K152172	Different
PowerSource	230V~, 50/60Hz110V~, 60HzAnd battery.	Universal power supply,from 100 V~ to 240V~. 1 phase, 1.1 kVA	110/115/127/220/230VCA-50/60 Hz andBatteries	similar
Meets USPerformanceStandard	YES 21 CFR 1020.30 and1020.31	YES 21 CFR 1020.30and 1020.31	YES 21 CFR 1020.30and 1020.31	same
PanelInterface	Ethernet or Wi-Fi wireless	Ethernet or Wi-Fi wireless	Ethernet or Wi-Fiwireless	same

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The differences between the proposed device and the predicate device are the collimator and the software. The proposed device collimator (X5300) was tested with the system according to FDA

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recognized standards ANSI/AAMI ES60601-1, IEC60601-1-3 and IEC 60601-2-54. The proposed software: PLX5200 workstation software and 5200 Embedded Software were validated and comply with FDA recognized standard IEC 62304.

The results of non-clinical bench performance testing indicate that the proposed deviceare as safe and effective as the predicate devices.

VIII Performance Data

The following performance data were provided in support of the substantial equivalence determination. Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the proposed device. The system complies with IEC 60601-1:2005+A1:2012 / ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-3:2008+A1:2013, IEC 60601-2-54:2009 , IEC 62471 standard for safety, and and IEC 60601-1-2: 2014 standard for EMC, and Radio frequency (RF) wireless coexistence of equipment testing was performed according to IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.

Software

Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The Embedded software and the workstation software for this device was considered as a "Moderate" level of concern, since a failure could result in minor injury to the patient or operator.

Cybersecurity

The cybersecurity documentation was provided according to Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

DICOM
DICOM declaration was provided according to FDA recognized standard NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set.

Usability Testing

Usability validation was performed and documentation was provided complies with FDA recognized standard IEC 60601-1-6 Edition 3.1 and EC 62366-1 Edition 1.0.

Risk management

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Risk management activities were performed throughout the time, and the documentations were provided according to FDA recognized standard ISO 14971 Second edition 2007-03-01 Medical devices - Application of risk management to medical devices.

Biocompatibility Testing

The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility testing for the x-ray flat panel detector includes the following tests:

. Cytotoxicity
. Skin Sensitization
Skin irritation

IX Clinical Testing

No clinical study is included in this submission.

X Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.