(58 days)
No
The summary describes a standard portable X-ray unit and its components. While it mentions "image processing software" used with the detector and computer, there is no mention of AI, ML, or any related technologies being integrated into the device itself or the described software. The focus is on the hardware and basic control software for generating X-rays.
No.
The device is described as an "X-ray device, intended for use ... for the purpose of acquiring X-ray images" and "for handheld diagnostic imaging," which means its primary function is for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "The device may be used for handheld diagnostic imaging of body extremities" and "The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities."
No
The device description clearly outlines multiple hardware components including an X-ray main unit, exposure hand switch, charger, high-voltage tank, collimator, and lithium-ion battery. While it mentions system control software, this software is integral to the operation of the physical X-ray unit and is not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The SR-8230/SR-8230S Portable X-ray Unit is an imaging device that uses X-rays to create images of the internal structures of the patient's body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states the purpose is "acquiring X-ray images of the desired parts of patient's anatomy". This is a direct imaging function, not an in vitro analysis.
Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SR-8230/SR-8230S Portable X-ray Unit is a portable X-ray device, 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).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
- -The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
- -The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
Product codes
IZL
Device Description
This SR-8230/SR-8230S Portable X-ray Unit 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: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit. See the photos below (Fig. 1 and Fig. 2). The difference between SR-8230 and SR-8230S is the operation interface of the device only. The SR-8230 has the display interface with button-operation digital tube, while the SR-8230S has the display interface with touch screen operation. Except for the difference above, the 2 models (SR-8230 and SR-8230S) are completely the same in all the other mechanical and circuit design.
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.
Mentions image processing
The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained physician or technician; facilities with mobile or fixing sites
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the primary predicate. Clinical testing was not necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Flower Cai Liaison Manager 77 Jinsha Road Shantou. Guangdong 515041 CHINA
Re: K200976
Trade/Device Name: SR-8230 Portable X-ray Unit SR-8230S Portable X-ray Unit Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: April 10, 2020 Received: April 13, 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
June 10, 2020
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200976
Device Name SR-8230 Portable X-ray Unit SR-8230S Portable X-ray Unit
Indications for Use (Describe)
The SR-8230/SR-8230S Portable X-ray Unit is a portable X-ray device, 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).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
- -The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
- -The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
| Type of Use (Select one or both, as applicable) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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: K200976
Submitter 5.1
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
77 Jinsha Road, Shantou, Guangdong 515041, China
Tel: 86-754-88250150
Fax: 86-754-88251499
Contact Person: Flower Cai
Shantou Institute of Ultrasonic Instruments Co., Ltd.
77 Jinsha Road, Shantou, Guangdong 515041, China
Date prepared: June 4, 2020
5.2 Device
Name of Device: SR-8230 Portable X-ray Unit
SR-8230S Portable X-ray Unit
Classification Name: Mobile x-ray system (21 CFR 892.1720)
Regulatory Class: II
Product Code: IZL
Predicate Device 5.3
The SR-8230/SR-8230S Portable X-ray Unit 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: TR90BH
4
Classification Name: Mobile x-ray system (21 CFR 892.1720)
Regulatory Class: II
Product Code: IZL
Name of Reference Device: JADE Mobile X-Ray
Classification Name: Mobile x-ray system (21 CFR 892.1720)
Regulatory Class: II
Product Code: IZL
| Legally Marketed
Device | Manufacturer | Model | 510(k)
Control
Number |
|-----------------------------|-------------------|----------------------|-----------------------------|
| Primary
predicate device | MinXray, Inc | TR90BH | K182207 |
| Reference device | DRGEM Corporation | JADE Mobile
X-Ray | K183388 |
5.4 Device Description
This SR-8230/SR-8230S Portable X-ray Unit 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: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit. See the photos below (Fig. 1 and Fig. 2). The difference between SR-8230 and SR-8230S is the operation interface of the device only. The SR-8230 has the display interface with button-operation digital tube, while the SR-8230S has the display interface with touch screen operation. Except for the difference above, the 2 models (SR-8230 and SR-8230S) are completely the same in all the other mechanical and circuit design.
5
Image /page/5/Figure/1 description: The image contains two figures of portable X-ray units. The first figure, labeled "Fig.1 SR-8230 Portable X-ray Unit", shows the unit with labels pointing to the handle, control panel, enclosure, and collimator. The second figure, labeled "Fig 2 SR-8230S Portable X-ray Unit", shows a similar unit with the same labels pointing to the corresponding parts.
Fig.2 SR-8230S Portable X-ray Unit
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
6
SIUI SR-8230/SR-8230S Portable X-ray Unit
circuit modules inside the portable X-ray unit. 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 device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. The portable X-ray unit SR-8230 /SR-8230S is designed for handheld or stand-mounted imaging. The portable X-ray unit SR-8230 / SR-8230S can be configured to an optional portable stand/rack (see Fig. 3) or use a stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 30kgs to ensure the mechanical stability and effectiveness of the device.
Image /page/6/Picture/3 description: The image shows a portable X-ray machine. The machine is white and gray, and it has a long arm that extends from the base to the X-ray head. The base has wheels, which makes it easy to move the machine around. The X-ray head is box-shaped and has a control panel on the front.
Fig. 3
7
Indications for Use ર્સ રાજ્યના સાથે તેમની સાથે અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને અને જિલ્લાના આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેત
The SR-8230/SR-8230S Portable X-ray Unit is a portable X-ray device, 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).
The device may be used for handheld diagnostic imaging of body extremities. The system is subject to the following limitations of use when stand-mounted:
- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
-The device may be used for imaging of the chest when used without a grid. This device is not intended for mammography.
5.6 Comparison of Technological Characteristics with the Predicate Device
The comparison between the overall specifications of predicate device (TR90BH) and the new device (SR-8230/SR-8230S) is shown in Table 1, and the comparison between the Collimator specifications of reference device (JADE Mobile X-ray) and the new device (SR-8230/SR-8230S) is shown in Table 2. 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.
8
| Subject Device | Predicate Device | |
|---|---|---|
| Description | SR-8230/SR-8230S | TR90BH (K182207) |
| Indications for use | The SR-8230/SR-8230S Portable X-ray Unit is a portable X-ray device, 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). The device may be used for handheld diagnostic imaging of body extremities. | |
| The system is subject to the following limitations of use when stand-mounted: |
- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
-The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography | The TR90BH is a portable X-ray system with following limitations of use:
The device may be used for handheld diagnostic imaging of body extremities
The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device may be used for stand mounted imaging of the chest when used without a grid.
Not to be used on bariatric patients, unless imaging body extremities
Not for mammography use.
The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types. |
| Description | Subject Device
SR-8230/SR-8230S | Predicate Device
TR90BH (K182207) |
| Comment on
Indications | Original Indications | Certain limitations apply
because of the lower maximum kVp output as compared to the predicate and because of the possibility of handheld use on extremities. See indications above. |
| Weight | 15kgs(33.06lb)
(Including Collimator) | 7.5kgs(16.53lb)
(Including Collimator) |
| Size | 460mm×245mm×188mm | 219 mm x 442 mm x 190 mm |
| Energy Source | Lithium-ion Rechargeable Battery
(44.4V DC),
300 exposures per charge | Lithium-ion Rechargeable Battery (57.6VDC),
300 exposures per charge. |
| Use Interface | SR-8230: Soft touch push buttons
SR-8230S: Touch screen | Soft touch push buttons |
| Exposure time | 0.02 sec – 6.3 sec: R'10 sec Step | 0.01sec – 1.0 sec :0.01 sec Step
High Power Mode
0.01 sec – 0.3 sec:0.01 sec Step |
| Memory Settings
(technique) | 16 memories | 5 memories |
| HF Generator | High Frequency | High Frequency |
| kW | 5.0kW | 1.35kW |
| kVp | 40-125kVp | 40-90kVp |
| Description | Subject Device
SR-8230/SR-8230S | Predicate Device
TR90BH (K182207) |
| mA | 10mA-100mA: R'10 sec
Step | 20 mA @ 40kVDC – 60kVDC
(2kVP steps)
15 mA @ 62kVDC – 80kVDC
(2kVP steps)
10 mA @ 82kVDC – 90kVDC
(2kVP steps)
High Power Mode
15 mA @ 82kVDC – 90kVDC
(2kVP steps)
0.02Comment: 90 kVP
maximum instead of 120 kVP
maximum. |
| FDA
Performance
Standard | Complies | Complies |
| Collimator | SIUI SR-8200-39L | Mikasa BLD34L |
Table 1 Subject and Predicate (TR90BH) Device Comparison
9
10
Table 2 Subject and Reference Device (JADE-32) Comparison
| Table 2 Subject and Reference Device (JADE-32) Comparison | ||
|---|---|---|
| Description | Subject Device | |
| SR-8230/SR-8230S | Reference Device | |
| JADE-32 (K183388) | ||
| Output Rating | Max. | |
| 5.0kW(40mA@125kV) | Max. 3.2kW(40mA@ 80kV, | |
| 32mA@100kV,25mA@120kV) | ||
| Type | Microprocessor controlled High Frequency inverter | Microprocessor controlled High Frequency inverter |
| kV Range | 40~125kV,86 Step (1kV Step) | 40~120kV,81 Step (1kV Step) |
| mA Range | 10~100mA, 11 Steps | |
| (10,12.5,16,20,25,32,40,50,64,80,100mA) | 10~80mA, 10 Step | |
| (10,12.5,16,20,25,32,40,50,64,80 mA) | ||
| Exposure Time | 0.02~6.3seconds, | |
| 26 Step (in 25% Steps) | 0.01~10 seconds, | |
| 21 Step (in 25% Steps) | ||
| mAs Range | 0.4~200mAs, | |
| 28 Step ( in 25% Steps) | 0.1~250mAs, | |
| 35 Step ( in 25% Steps) |
11
SIUI SR-8230/SR-8230S Portable X-ray Unit
| Portable X-ray Unit | ||
|---|---|---|
| Description | Subject Device | |
| SR-8230/SR-8230S | Reference Device | |
| JADE-32 (K183388) | ||
| X-ray Tube | ||
| Type | Stationary Anode | Stationary Anode |
| Focal Spot Size | ||
| (Small/Large) | 0.6/1.8mm | 0.5/1.5mm |
| Anode Heat | ||
| Storage | ||
| Capacity | 42,000HU (30,000J) | 56,000HU (40,000J) |
| Power Cord | ||
| Length | 3m | 5m |
| Exposure | ||
| Hand-switch | ||
| Cord Length | 6m (Max. Length) | 5m (Max. Length) |
| X-ray switching | ||
| frequency | 100kHz | 100kHz |
| Control | 2 Point Control (kV, mAs) | 2 Point Control (kV, mAs) |
| Anatomical | ||
| Programs | Preprogrammed 16 APR data- User Programmable | Preprogrammed 9 APR data- User Programmable |
Table 3 Collimator Specs Comparison
| Description | Subject Device
SIUI SR-8230/SR-8230S | Reference Device
DRGEM JADE Mobile X-Ray
System (K183388) |
|----------------------|----------------------------------------------|-----------------------------------------------------------------|
| Model | SR-8200-39L | KM1 |
| Manufacturer | SIUI | DRGEM |
| Control | Manual with 15, 30, 45,
60sec. Lamp timer | Manual with 15, 30, 45, 60sec.
Lamp timer |
| Field Shape | Rectangular | Rectangular |
| Max. Field Size | 44x44cm (at 100cm SID) | 44x44cm (at 100cm SID) |
| Leakage
Radiation |