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

K240284 · Shenzhen Browiner Tech Co., Ltd. · IZL · Mar 28, 2024 · Radiology

Device Facts

• Record ID: K240284
• Device Name: Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H)
• Applicant: Shenzhen Browiner Tech Co., Ltd.
• Product Code: IZL · Radiology
• Decision Date: Mar 28, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Intended Use

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 Story

Mobile X-ray system (MobileApex 60E/F/G/H) captures diagnostic radiographic images of adult patients. System comprises 63kW high-voltage generator, X-ray tube, collimator, and digital detector (CareView/Mars/Luna series). Operated by qualified clinicians in medical facilities/universities; patient positioned sitting, standing, or supine. Device transforms X-ray radiation into digital images via detector and operator console software. Clinicians view images on console to support diagnostic decision-making. Benefits include rapid, high-quality radiographic imaging for various anatomical regions.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance demonstrated via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), radiation protection (IEC 60601-1-3, IEC 60601-2-54), software validation (IEC 62304), and usability (IEC 62366-1).

Technological Characteristics

Mobile X-ray system; 63kW generator; Rhenium-Tungsten Molybdenum X-ray tube; rotating anode. Connectivity via Wi-Fi (802.11a/b/g/n/ac) and Ethernet. Digital detectors (CareView/Mars/Luna). Software-based image acquisition/control. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, 21 CFR 1020.30/31.

Indications for Use

Indicated for adult subjects requiring diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Contraindicated for mammography.

Regulatory Classification

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.

Predicate Devices

• MX40 Mobile Digital X-ray System (K181874)

Reference Devices

• CareView 1500Cwe (K201932)
• Mars1417X (K210316)
• Mars1717X (K210314)
• CareView 750Cw (K163019)
• Luna 1012X (K221345)
• Varian 4336R PAXSCAN 4336W (K161459)
• ECOM Digital Radiography Operator Console (K130883, K143232)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> × Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone]

Fax: [phone]

E-mail: [e-mail]

### 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: [phone]

Fax: [phone]

E-mail: [e-mail]

3. 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 | Machine<br>MX40 Mobile Digital X-ray System | K181874 |
| Corporation | | |

#### 6. 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

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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

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.

#### 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 60E<br>MobileApex 60F<br>MobileApex 60G<br>MobileApex 60H | MX40 | |
| 510(k) number | / | K181874 | |
| Submitter | Shenzhen Browiner Tech Co., Ltd | Huestis Machine Corporation | |
| Intended use | Intended for use by a qualified/trained<br>doctor or technician on adult subjects for | Intended for use by a qualified/trained<br>doctor or technician on both adult and | |
| Item | Proposed Device | Predicate Device | |
| | taking diagnostic radiographic exposures of<br>the skull, spinal column, chest, abdomen,<br>extremities, and other body parts.<br>Applications can be performed with the<br>patient sitting, standing, or lying in the<br>prone or supine position. Not for<br>mammography. | pediatric subjects for taking diagnostic<br>radiographic exposures of the skull, spinal<br>column, chest, abdomen, extremities, and<br>other body parts. Applications can be<br>performed with the patient sitting, standing,<br>or lying in the prone or supine position. Not<br>for mammography. | |
| General Information | | | |
| Modes of<br>Operation | Manual | Manual | |
| Classification<br>Name | Mobile X-ray System | Mobile X-ray System | |
| Classification<br>Panel | Radiology | Radiology | |
| Classification<br>Regulation | 21 CFR 892.§1720 | 21 CFR 892.§1720 | |
| Product Code | IZL | IZL | |
| Subsequent<br>Product Code | MQB | MQB | |
| Medical Device<br>Class | Class II | Class II | |
| Performance<br>Standard | 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 -<br>240 Vac (+/-10%) | |
| Electrical<br>Safety and<br>EMC | IEC 60601-1 and IEC 60601-1-2 | IEC 60601-1 and IEC 60601-1-2 | |
| Standards<br>(Other than<br>Electrical and<br>EMC) | WiFi 802.11a/b/g/n/ac and: FCC Rules and<br>Regulations | Wi-Fi 802.11b/g and: FCC Rules and<br>Regulations | |
| Item | Proposed Device | Predicate Device | |
| Generator | | | |
| Type | BWG-50-500D, manufactured by Shenzhen Browiner | Shenzhen Browiner | |
| Generator<br>Power Level | Nominal Power: 63 kW (630 mA, 100 kV, 100 ms)<br>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%<br>Contain the following mA slot:<br>10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32,<br>36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110,<br>125, 140, 160, 180, 200, 220, 250, 280, 320,<br>360, 400, 450, 500, 560, 630 | 10 - 630 mA | |
| Exposure Time<br>Range | 1 - 10000 ms, ± (10%+1 ms)<br>Contain the following time slot:<br>1.0, 1.1, 1.25, 1.4, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8,<br>3.2, 3.6, 4.0, 4.5, 5.0, 5.6, 6.3, 7.1, 8.0, 9.0,<br>10, 11, 12.5, 14, 16, 18, 20, 22, 25, 28, 32,<br>36, 40, 45, 50, 56, 63, 71, 80, 90, 100, 110,<br>125, 140, 160, 180, 200, 220, 250, 280, 320,<br>360, 400, 450, 500, 560, 630, 710, 800, 900,<br>1000, 1100, 1250, 1400, 1600, 1800, 2000,<br>2200, 2500, 2800, 3200, 3600, 4000, 4500,<br>5000, 5600, 6300, 7100, 8000, 9000, 10000 | 0.001 - 6.3 sec | |
| mAs Range | 0.1 - 630 mAs, ± (10 % + 0.2 mAs)<br>Contain the following mAs slot:<br>0.1, 0.11, 0.125, 0.14, 0.16, 0.18, 0.2, 0.22,<br>0.25, 0.28, 0.32, 0.36, 0.4, 0.45, 0.5, 0.56,<br>0.63, 0.71, 0.8, 0.9, 1.0, 1.1, 1.25, 1.4, 1.6,<br>1.8, 2.0, 2.2, 2.5, 2.8, 3.2, 3.6, 4.0, 4.5, 5.0,<br>5.6, 6.3, 7.1, 8.0, 9.0, 10, 11, 12.5, 14, 16,<br>18, 20, 22, 25, 28, 32, 36, 40, 45, 50, 56, 63,<br>71, 80, 90, 100, 110, 125, 140, 160, 180,<br>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-150/30/50<br>Canon E7252X | Toshiba E7843X | |
| Material | Rhenium-Tungsten Molybdenum | Rhenium-Tungsten Molybdenum | |
| Max Voltage | 150 kV | 150 kVp | |
| Nominal Focal<br>Spot | SDR-150/30/50: 0.6/1.0<br>E7252X: 0.6/1.2 | 0.6/1.2 | |
| Anode type | Rotating | Rotating | |
| Nominal Anode<br>Input Power | SDR-150/30/50:<br>Small focus 43kW @ 180Hz<br>Large Focus 81kW @ 180Hz<br>E7252X:<br>Small focus 27kW @ 180Hz<br>Large Focus 75kW @ 180Hz | Large Focus 50kW @ 6Hz<br>Small focus 22kW @ 60Hz | |
| Imaging Panel | | | |
| Image<br>acquisition<br>panels (Both<br>systems<br>use already<br>cleared digital<br>panels) | CareView 1500Cwe (K201932)<br>Pixels size: 140 μm<br>3072×2560 pixels<br>Mars1417X (K210316)<br>Pixels size: 100 μm<br>4300×3500 pixels<br>Mars1717X (K210314)<br>Pixels size: 100 μm<br>4267×4267 pixels<br>CareView 750Cw (K163019)<br>Pixels size: 120 μm<br>2560×2048 pixels<br>Luna 1012X (K221345)<br>Pixels size: 100 μm<br>3152×2502 pixels | Varian 4336R<br>PAXSCAN 4336W<br>Pixel Size 144 μm/3072 x 2560 pixels<br>(previously cleared as part of K161459,<br>09/06/2016) | |
| Item | Proposed Device | Predicate Device | |
| System Software | Image acquisition and control Software | MOC (V05) | ECOM Digital Radiography Operator Console<br>(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 performance<br>IEC60601-1-2 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 performance<br>IEC60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral |
| Item | Proposed Device | Predicate Device | |
| | standard: Electromagnetic compatibility -<br>Requirements and tests. | standard: Electromagnetic compatibility -<br>Requirements and tests. | |
| | IEC60601-1-3 Medical electrical equipment<br>Part 1-3: General requirements for basic<br>safety and essential performance – | IEC60601-1-3 Medical electrical equipment<br>Part 1-3: General requirements for basic<br>safety and essential performance – | |
| | Collateral standard: Radiation protection in<br>diagnostic X-Ray equipment | Collateral standard: Radiation protection in<br>diagnostic X-Ray equipment | |
| | IEC60601-2-54 Medical electrical<br>equipment Part 2-54: Particular<br>requirements for the basic safety and<br>essential performance of X-Ray equipment<br>for radiography and radioscopy | IEC60601-2-54 Medical electrical<br>equipment Part 2-54: Particular<br>requirements for the basic safety and<br>essential performance of X-Ray equipment<br>for radiography and radioscopy | |
| | IEC62304 Medical device software –<br>Software life-cycle processes | IEC62304 Medical device software –<br>Software life-cycle processes | |
| | 21CFR 1020.30 Diagnostic X-Ray systems<br>and their major components | 21CFR 1020.30 Diagnostic X-Ray systems<br>and their major components | |
| | 21CFR 1020.31 Radiographic equipment…