SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System

K202353 · Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · IZL · Dec 23, 2020 · Radiology

Device Facts

• Record ID: K202353
• Device Name: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
• Applicant: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
• Product Code: IZL · Radiology
• Decision Date: Dec 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2

Indications for Use

Intended for use by a qualified/trained physician or the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.

Device Story

Portable DR imaging system for X-ray acquisition in mobile or fixed clinical sites. Components: portable X-ray unit, flat panel detector, workstation. Input: X-ray radiation through patient anatomy. Detector scintillator converts X-rays to visible light; amorphous silicon converts light to digital signals. Workstation (PIE-5) performs image reconstruction, display, storage, and transmission via Gigabit Ethernet. Operated by physician or technician. System control software manages kV/mAs parameters, high-voltage tank, and collimator. Output: diagnostic X-ray images. Benefits: enables portable radiographic imaging for diagnosis. Device supports wired/wireless connectivity.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-3, ISO 14971, and ISO 10993 series. Clinical images were provided as supplemental evidence but were not required to establish substantial equivalence.

Technological Characteristics

Portable X-ray system; amorphous silicon TFT flat panel detector; 14"x17" detector size; 150 µm pixel pitch. Energy source: AC line or rechargeable battery. Connectivity: Wired/Wireless (IEEE 802.11a/g/n). Software: Embedded system control (ARM/C) and PIE-5 workstation (Windows/C). Standards: IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-3, ISO 10993, ISO 14971.

Indications for Use

Indicated for use by qualified/trained physicians or technicians to acquire X-ray images of head, cervical spine, chest, abdomen, lumbar spine, pelvis, and extremities. Not intended 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

• AcuityPDR (K200726)

Reference Devices

• SR-8230 (K200976)
• SR-8230S (K200976)
• AcuityDR (K171137)
• AccuVueMED (K152172)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

December 23, 2020

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Flower Cai Liaison Manager 77 Jinsha Road Shantou, Guangdong 515041 CHINA

### Re: K202353

Trade/Device Name: SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL, MQB, LLZ Dated: November 20, 2020 Received: November 30, 2020

### Dear Flower Cai:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Enclosure

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# Indications for Use

510(k) Number (if known) K202353

#### Device Name

SR-2300 Portable DR Imaging System SR-2300S Portable DR Imaging System

#### Indications for Use (Describe)

Intended for use by a qualified/trained physician or the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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 provided in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

The assigned 510(k) number is: K202353

#### Submitter 5.1

Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)

77 Jinsha Road, Shantou, Guangdong 515041, China

Tel: [phone]

Fax: [phone]

Contact Person: Flower Cai

Shantou Institute of Ultrasonic Instruments Co., Ltd.

77 Jinsha Road, Shantou, Guangdong 515041, China

Date Prepared: Nov 13, 2020

# 5.2 Device

Name of Device: SR-2300 Portable DR Imaging System

SR-2300S Portable DR Imaging System

Classification Name: Mobile x-ray system (21 CFR 892.1720)

Regulatory Class: II

Product Code: IZL, MQB, LLZ

#### Predicate Device 5.3

The SR-2300/SR-2300S Portable DR Imaging System is for X-ray imaging and diagnosis, image acquisition in facilities with mobile or fixing sites, and is substantially equivalent to the predicate device.

Name of Predicate Device: AcuityPDR (K200726)

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Classification Name: Mobile x-ray system (21 CFR 892.1720)

Regulatory Class: II

Product Code: IZL, MQB, LLZ

### 5.4 Device Description

This SR-2300/SR-2300S Portable DR Imaging System is a portable digital device developed, designed and manufactured by SIUI. A detailed comparison table with an equivalent device is provided below. The device consists of the following major components: a portable X-ray unit, a flat panel detector, and workstation. The difference between SR-2300 and SR-2300S is the operation interface of the portable X-ray Unit only, while the flat panel detector and the workstation are the same for SR-2300 and SR-2300S. The SR-2300S has the display interface with button-operation digital tube, while the SR-2300 has the display interface with touch screen operation. Except for the difference above, the 2 models (SR-2300 and SR-2300S) are completely the same in all the other mechanical and circuit design. See the photos below (Fig. 1 and Fig. 2).

Image /page/4/Picture/6 description: The image shows a portable X-ray machine. The machine consists of a detector, an X-ray generator, and a laptop. The detector is a flat panel that captures the X-ray image. The X-ray generator produces the X-rays. The laptop is used to control the machine and view the images.

Fig.1 SR-2300S Portable DR Imaging System

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Image /page/5/Picture/1 description: The image shows a portable X-ray machine. The machine consists of a detector panel, an X-ray generator, and a laptop computer. The detector panel is a flat, rectangular device that is used to capture the X-ray image. The X-ray generator is a small, portable device that produces the X-rays. The laptop computer is used to control the X-ray generator and to view the X-ray image.

Fig.2 SR-2300 Portable DR Imaging System

The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the SYS board.

The system control software is for real-time interaction and control with various circuit modules inside the Portable DR Imaging System. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~125kVp, which is not suitable for breast exams, the device is not intended for mammography.

The flat panel detector is the core of image acquisition of the system. The X-ray emitted through the human body is converted by the scintillator of flat panel detector to visible optical signals, which are then converted to digital signals by the amorphous 510(k) Summary TAB 2 Section 5 Page 3 of 9

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silicon of flat panel detector. The processed digital signals are sent to the image workstation for image reconstruction, display, storage and transmission via a Gigabit Ethernet cable. The image workstation is installed with a PIE-5 DR Workstation, which is the core of image acquisition and processing on the system.

#### Indications for Use ર્ડ

Intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).This device is not intended for mammography.

#### Comparison of Technological Characteristics with the Predicate Device 5.6

The comparison between the overall specifications of the predicate device (AcuityPDR) and the new device (SR-2300/SR-2300S) is shown in Table 1. Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.

| Description | Predicate Device AcuityPDR<br>(K200726) | Subject Device<br>SR-2300/SR-2300S | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Intended for use by a<br>qualified/trained physician or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic x-rays. Not for<br>mammography. | Intended for use by a<br>qualified/trained physician or<br>technician for the purpose of<br>acquiring X-ray images of the<br>desired parts of patient's<br>anatomy (including head,<br>cervical spine, chest, abdomen,<br>lumbar spine, pelvis and<br>extremities).This device is not<br>intended for mammography. | |
| X-ray Generator(s) Model | -- | SR-8230 (K200976) or<br>SR-8230S (K200976) | |
| Generator Photos | Image: AcuityPDR Generator | SR-8230<br>Image: SR-8230 Generator<br>SR-8230S<br>Image: SR-8230S Generator | |
| | | Predicate Device AcuityPDR | Subject Device |
| Description | | (K200726) | SR-2300/SR-2300S |
| | Peak<br>generator | 2kW | ടിംസ |
| Basic<br>Generator<br>Characteristics | Tube<br>current | 40-60kV:25mA<br>61-100kV:20mA | 10-100mA |
| | Tube<br>voltage<br>adjustabl<br>e range | 40-100kV,step value 1kV | 40-125kV,step value 1kV |
| | mAs<br>range | 0.4mAs-50mAs,with the range<br>of :<br>0.40,0.50,0.63,0.80,1.00,1.25,1<br>.6,2.0,2.5,3.2,4.0,5.0,6.3,8,10,1<br>2.5,16,20,25,32,40,50 | 0.4mAs-200mAs,with the range<br>of :<br>0.40,0.50,0.63,0.80,1.00,1.25,1.6<br>,2.0,2.5,3.2,4.0,5.0,6.3,8,10,12.5,<br>16,20,25,32,40,50,63,80,100,125<br>,160,200 |
| Collimator | | Built in | Built in |
| X-ray Generator | | One model ,up to 100kVp | One model ,up to 125kVp |
| Operator console | | Touch<br>Control<br>or<br>Touch<br>Screen | Button Control or Touch Screen |
| Digital X-Ray Detectors | | AcuityDR (K171137) | SFD-1X |
| Panel Shape | | Rectangular Panel | Rectangular Panel |
| Detector Size | | 13" X 17" | 14" X 17" |
| Pixel Pitch | | 140 μm | 150 µ m |
| Materials Scintillator | | TFT -amorphous<br>Silicon | TFT —amorphous<br>Silicon |
| DQE | | 25% at 1.0 lp/mm<br>5% at 3.0 lp/mm | 36% at 1.0 lp/mm<br>13% at 3.0 lp/mm |
| MTF | | 35% at 2.0 lp/mm | 38% at 2.0 lp/mm |
| Communication<br>Method | | Wire<br>Wireless<br>IEEE 802.11a//g/n(2.4GHz/<br>5GHz)<br>Security: WEP/WPA/WPA2 | Wire<br>Wireless<br>IEEE 802.11a//g/n(2.4GHz/<br>5GHz)<br>Security: WEP/WPA/WPA2 |
| Acquisition Software | | AccuVueMED (K152172) | PIE-5 |
| Software function | | Image viewing<br>Image search<br>Image storage<br>Image annotation | Image viewing<br>Image search<br>Image storage<br>Image annotation |
| | Predicate Device AcuityPDR<br>(K200726) | Subject Device<br>SR-2300/SR-2300S | |
| Description | Image measurement<br>Image processing<br>Image stitch | Image measurement<br>Image processing<br>Image stitch | |
| DICOM 3.0 Compatibility | Yes | Yes | |
| Photos | Image: AcuityPDR device | Image: SR-2300/SR-2300S device<br>Note: The portable stand is an optional component. | |
| Power Source | AC Line or rechargeable batteries (Generator only) | AC Line or rechargeable batteries | |

Tahle 1

TAB 2 Section 5

510(k) Summary

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#### SIUI SR-2300/SR-2300S Portable DR Imaging System

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# 5.7 Non-clinical Testing Summary

The SR-2300/SR-2300S Portable DR Imaging System complies with and/or was tested in accordance with the following FDA guidance and International Standards:

- . IEC 60601-1: 2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2: 2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC60601-2-54:2009+A1:2015+A2:2018 Medical electrical equipment Part . 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- IEC60601-1-3: 2008+A1:2013 Medical electrical equipment Part 1-3: General . requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment

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- ISO 14971: 2007 Medical device - Application of risk management to medical devices
- ISO 10993-1: 2018 Biological evaluation of medical devices-Part1: Evaluation . and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices-Part5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical devices - Part 10:Tests for irritation and skin sensitization
- IEC 62304:2006+AMD1:2015 Medical device software Software life cycle ● processes
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - collateral standard: Usability
- IEC 62366-1:2015/COR1:2016 Medical devices Application of usability . engineering to medical devices
- . ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- ISO 13485 :2016 Medical devices Quality management systems Requirements ● for regulatory purposes
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Radio Frequency Wireless Technology in Medical Devices ●
- Guidance for the Pediatric Information for X-ray Imaging Device Premarket Notifications

The subject device and the predicate device are comparable in terms of technical features, general functions, applications and intended uses. The test results showed compliance with the above standards. Validation was performed for overall operation by taking and reviewing test images. Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the predicate device, but they provide further evidence in addition to bench testing data to show that the complete system works as intended. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the

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predicate.

#### Software Description 5.8

The SR-2300/SR-2300S Portable DR Imaging System contains two software, one is the embedded software in the X-ray unit: system control software, and the other is PIE-5 DR Workstation (herein after referred to as "PIE-5").

The system control software of SR-2300/SR-2300S is new software designed by SIUI. The software adopts development languages of keil, the program language is C language, the hardware platform is ARM. The system control software is for real-time interaction and control with various circuit modules inside the Portable DR Imaging System. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, monitor the working status of the device and the battery power status, and control the display of the status indicators. The Level of Concern for the Software Device is Moderate.

The programming language of PIE-5 is C language, and the operating platform is Microsoft Windows. The software is a medical image processing system, consisting of image acquisition, image review and diagnosis, image processing and digital storage functions, which mainly address digital image workflow in radiographic department of hospitals. The functions of the software include patient registration, image acquisition and processing, image review and diagnosis, image printing, report editing and PACS transmission, digital image storage and recovery. The Level of Concern for the Software Device is Moderate.

#### 5.9 Clinical Testing

Clinical testing is not necessary for the SR-2300/SR-2300S Portable DR Imaging System in order to demonstrate substantial equivalence to the predicate device.

### 5.10 Label

The labels on the device show that this device conforms to the following:

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21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products.

## 21 CFR 1020.30: Diagnostic x-ray systems and their major components,

- 21 CFR 1020.31: Radiographic Equipment .
## 5.11 Conclusion

The subject device SR-2300/SR-2300S system and the predicate device are comparable in terms of technical features, general functions, applications and indications for use.

Compared with the predicate device, the power of the SR-2300/SR-2300S is higher. The SR-2300/SR-2300S can be used for imaging including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities, and the predicate device AcuityPDR can be used for both adult and pediatric subjects for taking diagnostic x-rays. Nevertheless, it does not affect the safety and effectiveness of the SR-2300/SR-2300S, nor does it change the indications for use of the SR-2300/SR-2300S unit.

The indications for use of the SR-2300/SR-2300S Portable DR Imaging System do not create new potential safety risks, and its performance is comparable as that of the marketed products. Therefore, the device is as safe and effective as the legally marketed predicate device.