Intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Device Description

The Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) is comprised of a High Voltage Generator with a maximum power output of 63kW, the Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60C, MobileApex 60H) can meet different exposure needs for varying positions and body mass. With the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.

AI/ML Overview

Based on the provided text, the device in question is a Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H). The acceptance criteria and the study proving the device meets these criteria are focused on demonstrating substantial equivalence to a predicate device, the MX40 Mobile Digital X-ray System (K181874), rather than proving a specific, quantitative performance metric for a clinical application (like detection of a disease).

The documentation primarily discusses non-clinical performance tests related to electrical safety, electromagnetic compatibility, radiation protection, software validation, and usability. There is no mention of a clinical study to assess diagnostic performance (e.g., accuracy in detecting specific conditions).

Therefore, the following information is extracted and where information is not provided in the text, it is explicitly stated as "Not provided in the text."

Acceptance Criteria and Device Performance for Digital Radiography System

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness, primarily through compliance with recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on substantial equivalence)	Reported Device Performance (based on non-clinical testing)
1. Similar Intended Use: Intended for diagnostic radiographic exposures of various body parts on adult subjects (skull, spinal column, chest, abdomen, extremities). Not for mammography.	Device confirmed to have the "similar intended use" as the predicate.
2. Similar Technological Characteristics: (e.g., Mobile X-ray System, Manual Operation, Radiology Panel, Class II, 21 CFR 892.1720 Regulation, IZL/MQB Product Code, operates on battery/line, 100-240V, uses specific X-ray tubes, specific imaging panels (already cleared), Windows OS, DICOM, Wi-Fi).	The comparison table (Section 8) explicitly states that the "Proposed Device has the similar intended use, similar technological characteristics as the predicate device." Key specifications are provided and compared to the predicate, with minor differences acknowledged (e.g., generator power level is 63 kW for proposed vs. 50 kW for predicate, but this is not identified as raising new safety/effectiveness issues).
3. Safety and Effectiveness: Compliance with relevant international and FDA standards for medical electrical equipment, radiation protection, software life cycle, usability, and diagnostic X-ray systems.	The device has been tested and found compliant with:IEC 60601-1 (General requirements for basic safety and essential performance)IEC 60601-1-2 (Electromagnetic disturbances)IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment)IEC 60601-2-54 (Particular requirements for X-ray equipment for radiography and radioscopy)IEC 62304 (Medical device software - Software life cycle processes)IEC 62366-1 (Usability engineering)21 CFR 1020.30 (Diagnostic X-Ray systems)21 CFR 1020.31 (Radiographic equipment)All non-clinical testing results indicate the device is "as safe and effective as the predicate device."

2. Sample size used for the test set and the data provenance

Sample size for test set: Not applicable/Not provided. The summary describes non-clinical engineering and performance testing against standards, not a clinical test set with patient data for diagnostic performance.
Data provenance: Not applicable/Not provided. The testing described is type testing and verification against standards, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Ground truth in a diagnostic sense (e.g., for disease detection) was not established as part of this submission's described testing, which is focused on technical performance and safety.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical test set requiring adjudication of ground truth is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not done. This device is a mobile X-ray system, not an AI-powered diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device (X-ray system), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for diagnostic performance. For the described non-clinical performance tests (e.g., electrical safety, radiation output), the "ground truth" is defined by the requirements and specifications of the relevant international and FDA performance standards (e.g., IEC 60601 series, 21 CFR 1020.30/31).

8. The sample size for the training set

Not applicable/Not provided. This document describes a traditional medical device (X-ray system) and its non-clinical testing, not an AI/ML product that would require a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. (See point 8).

Summary

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March 28, 2024

Image /page/0/Picture/1 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.

Shenzhen Browiner Tech Co., Ltd % Long Yang COO, Shenzhen Hlongmed Biotech Company 16th Floor, Tianming Technology Building, No.8 Wushitou Road Songpingshan Community, Xili Street, Nanshan District, SHENZHEN, GD 518052 CHINA

Re: K240284

Trade/Device Name: Digital Radiography System (MobileApex 60E, MobileApex 60G, MobileApex 60H) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL, MQB Dated: January 31, 2024 Received: February 1, 2024

Dear Long Yang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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for

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Gabriela M. Digitally signed by Gabriela M. Rodal -S Rodal -S Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240284

Device Name

Digital Radiography System (MobileApex 60E, MobileApex 60G, MobileApex 60G, MobileApex 60H)

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

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(K) number is: K240284 -Date of Summary: March 27, 2024

1. Submitter

Shenzhen Browiner Tech Co., Ltd.

Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S REPUBLIC OF CHINA

2. Contact Person

2.1 Primary Contact Person

Long Yang (COO)

Shenzhen Hlongmed Biotech Company

16th floor, Tianming Technology Building, No.8 Wushitou Road, Songpingshan Community,

Xili Street, Nanshan District, Shenzhen, P.R.C

Tel: 0086-755-86664986

Fax: 0086-755-86664933

E-mail: yanglong@hlongmed.com

2.2 Secondary Contact Person

Li Chen(RA engineer)

Shenzhen Browiner Tech Co., Ltd.

Room 501, Building C, Ganghongji High-Tech Intelligent Industrial Park, No.1008, Songbai Road, Yangguang Community, Xili Street, Nanshan District, 518055 Shenzhen, PEOPLE'S

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REPUBLIC OF CHINA

Tel: 0086-15752770581

Fax: 0086-755-22674695

E-mail: lichen@browiner.com

Date Prepared: March 27, 2024

4. Proposed Device Information

Trade name: Digital Radiography System (MobileApex 60E, MobileApex 60F,

MobileApex 60G, MobileApex 60H)

Model: MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H

Common name: Digital Radiography System

Classification name: Mobile X-ray System

Review Panel: Radiology

Product Code:Primary Product Code: IZL; Secondary Product Code: MQB Regulation

Class: II

Regulation Number: 21 CFR 892.1720

	5. Predicate Device Information
--	---------------------------------

Manufacturer	Proprietary /Trade Name	510(K) Number
Huestis	MachineMX40 Mobile Digital X-ray System	K181874
Corporation

6. Device Description

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the Digital Radiography System's (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) state-of-the-art design and powerful 63kW generator coupled with the Digital Detector (CareView 1500Cwe, CareView 750Cw, Mars1717X, Mars1417X, Luna 1012X) and Digital Radiography Operator Console, users can obtain clear images quickly and easily.

7. Intended use

8. Comparison to Predicate Device

The Digital Radiography System have the similar intended use, similar technological characteristics as the following predicate device. Subject Device is substantially equivalent in its technologies and functionality to the MX40 Mobile Digital X-ray System manufactured by Huestis Machine Corporation that is already cleared under premarketed notification number K181874.

The details of the Technological Characteristics of Device as to Compare to the Predicate Device can are as below.

Item	Proposed Device	Predicate Device
Device Name	Digital Radiography System	MX40 Mobile Digital X-ray System
Model	MobileApex 60EMobileApex 60FMobileApex 60GMobileApex 60H	MX40
510(k) number	/	K181874
Submitter	Shenzhen Browiner Tech Co., Ltd	Huestis Machine Corporation
Intended use	Intended for use by a qualified/traineddoctor or technician on adult subjects for	Intended for use by a qualified/traineddoctor or technician on both adult and
Item	Proposed Device	Predicate Device
	taking diagnostic radiographic exposures ofthe skull, spinal column, chest, abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position. Not formammography.	pediatric subjects for taking diagnosticradiographic exposures of the skull, spinalcolumn, chest, abdomen, extremities, andother body parts. Applications can beperformed with the patient sitting, standing,or lying in the prone or supine position. Notfor mammography.
General Information
Modes ofOperation	Manual	Manual
ClassificationName	Mobile X-ray System	Mobile X-ray System
ClassificationPanel	Radiology	Radiology
ClassificationRegulation	21 CFR 892.§1720	21 CFR 892.§1720
Product Code	IZL	IZL
SubsequentProduct Code	MQB	MQB
Medical DeviceClass	Class II	Class II
PerformanceStandard	21CFR1020.30	21CFR1020.30
Configuration	Mobile Battery or Line Operated	Mobile Battery or Line Operated
Power Source	Single Phase Line, 100V-240V~, ±10%	Single Phase Line Regulation from 100 -240 Vac (+/-10%)
ElectricalSafety andEMC	IEC 60601-1 and IEC 60601-1-2	IEC 60601-1 and IEC 60601-1-2
Standards(Other thanElectrical andEMC)	WiFi 802.11a/b/g/n/ac and: FCC Rules andRegulations	Wi-Fi 802.11b/g and: FCC Rules andRegulations
Item	Proposed Device	Predicate Device
Generator
Type	BWG-50-500D, manufactured by Shenzhen Browiner	Shenzhen Browiner
GeneratorPower Level	Nominal Power: 63 kW (630 mA, 100 kV, 100 ms)Maximum Power: 63 kW (630 mA, 100 kV)	50 KW
kV Range	40 - 150 kV, in 1 kV steps, ±10%	40 - 150 KV
mA Range	10 - 630 mA, ±20%Contain the following mA slot:10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32,36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110,125, 140, 160, 180, 200, 220, 250, 280, 320,360, 400, 450, 500, 560, 630	10 - 630 mA
Exposure TimeRange	1 - 10000 ms, ± (10%+1 ms)Contain the following time slot:1.0, 1.1, 1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1, 8.0, 9.0,10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32,36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110,125, 140, 160, 180, 200, 220, 250, 280, 320,360, 400, 450, 500, 560, 630, 710, 800, 900,1000, 1100, 1250, 1400, 1600, 1800, 2000,2200, 2500, 2800, 3200, 3600, 4000, 4500,5000, 5600, 6300, 7100, 8000, 9000, 10000	0.001 - 6.3 sec
mAs Range	0.1 - 630 mAs, ± (10 % + 0.2 mAs)Contain the following mAs slot:0.1, 0.11, 0.125, 0.14, 0.16, 0.18, 0.2, 0.22,0.25, 0.28, 0.32, 0.36, 0.4, 0.45, 0.5, 0.56,0.63, 0.71, 0.8, 0.9, 1.0, 1.1, 1.25, 1.4, 1.6,1.8, 2.0, 2.2, 2.5, 2.8, 3.2, 3.6, 4.0, 4.5, 5.0,5.6, 6.3, 7.1, 8.0, 9.0, 10, 11, 12.5, 14, 16,18, 20, 22, 25, 28, 32, 36, 40, 45, 50, 56, 63,71, 80, 90, 100, 110, 125, 140, 160, 180,200, 220, 250, 280, 320, 360, 400, 450, 500,	0.1 - 320 mAs
Item	Proposed Device	Predicate Device
	560, 630
X-Ray Tube
Type	Siemens SDR-150/30/50Canon E7252X	Toshiba E7843X
Material	Rhenium-Tungsten Molybdenum	Rhenium-Tungsten Molybdenum
Max Voltage	150 kV	150 kVp
Nominal FocalSpot	SDR-150/30/50: 0.6/1.0E7252X: 0.6/1.2	0.6/1.2
Anode type	Rotating	Rotating
Nominal AnodeInput Power	SDR-150/30/50:Small focus 43kW @ 180HzLarge Focus 81kW @ 180HzE7252X:Small focus 27kW @ 180HzLarge Focus 75kW @ 180Hz	Large Focus 50kW @ 6HzSmall focus 22kW @ 60Hz
Imaging Panel
Imageacquisitionpanels (Bothsystemsuse alreadycleared digitalpanels)	CareView 1500Cwe (K201932)Pixels size: 140 μm3072×2560 pixelsMars1417X (K210316)Pixels size: 100 μm4300×3500 pixelsMars1717X (K210314)Pixels size: 100 μm4267×4267 pixelsCareView 750Cw (K163019)Pixels size: 120 μm2560×2048 pixelsLuna 1012X (K221345)Pixels size: 100 μm3152×2502 pixels	Varian 4336RPAXSCAN 4336WPixel Size 144 μm/3072 x 2560 pixels(previously cleared as part of K161459,09/06/2016)
Item	Proposed Device	Predicate Device
System Software	Image acquisition and control Software	MOC (V05)	ECOM Digital Radiography Operator Console(Acquisition Software and Graphical Interface-previously cleared as part of K130883 (04/18/13) and K143232 (01/30/15))
Operating System	Windows OS	Windows OS
Environment of use	Medical Facilities and/or Universities	Medical Facilities and/or Universities
Collimator	Model	BRC-60, manufactured by Shenzhen Browiner	Shenzhen Browiner Tech Co., Ltd Or Huestis 150MC
Operation	Manual, square/rectangular field, field indicator lamp	Manual, square/rectangular field, field indicator lamp
Anatomical Programs	500+ Anatomical settings	500+ Anatomical settings
External Connectivity	Connection	Wi-Fi and Ethernet Cable	Wi-Fi and Ethernet Cable
DICOM	YES	YES
Wi-Fi Communication with detectors	Wireless	Wireless
Standard	Applied standard	IEC60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral	IEC60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performanceIEC60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral
Item	Proposed Device	Predicate Device
	standard: Electromagnetic compatibility -Requirements and tests.	standard: Electromagnetic compatibility -Requirements and tests.
	IEC60601-1-3 Medical electrical equipmentPart 1-3: General requirements for basicsafety and essential performance –	IEC60601-1-3 Medical electrical equipmentPart 1-3: General requirements for basicsafety and essential performance –
	Collateral standard: Radiation protection indiagnostic X-Ray equipment	Collateral standard: Radiation protection indiagnostic X-Ray equipment
	IEC60601-2-54 Medical electricalequipment Part 2-54: Particularrequirements for the basic safety andessential performance of X-Ray equipmentfor radiography and radioscopy	IEC60601-2-54 Medical electricalequipment Part 2-54: Particularrequirements for the basic safety andessential performance of X-Ray equipmentfor radiography and radioscopy
	IEC62304 Medical device software –Software life-cycle processes	IEC62304 Medical device software –Software life-cycle processes
	21CFR 1020.30 Diagnostic X-Ray systemsand their major components	21CFR 1020.30 Diagnostic X-Ray systemsand their major components
	21CFR 1020.31 Radiographic equipment	21CFR 1020.31 Radiographic equipment

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9. Summary of non-clinical performance Tests

Digital Radiography System has been tested for electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54). The device also complies with FDA EPRC Performance Standard: 21CFR 1020.30 and 21CFR 1020.31. The software validation and verification testing was also performed and meets the requirements of IEC 62304. Usability was conducted according to IEC 62366-1. The results of nonclinical testing indicate that the Digital Radiography System is as safe and effective as the predicate device.

The Digital Radiography System has been tested to be in compliance with the following standards:

• IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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· IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

• IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION

Medical electrical equipment - Part 1-3: General requirements for basic safety and essential

performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

• IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and

essential performance of X-ray equipment for radiography and radioscopy

• IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION

Medical device software - Software life cycle processes

• IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION

Medical devices - Part 1: Application of usability engineering to medical devices

· 21CFR 1020.30 Diagnostic X-Ray systems and their major components
· 21CFR 1020.31 Radiographic equipment

10. Substantial Equivalent Conclusions

Digital Radiography System has the similar intended use, similar technological characteristics as the predicate device. Moreover, non-clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness.

In conclusion, Digital Radiography System is substantial 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.