X-ray Flat Panel Detectors/CareView 3600RF

K202995 · Careray Digital Medical System Co., Ltd. · MQB · Feb 19, 2021 · Radiology

Device Facts

• Record ID: K202995
• Device Name: X-ray Flat Panel Detectors/CareView 3600RF
• Applicant: Careray Digital Medical System Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Feb 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CareView 3600RF detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.

Device Story

CareView 3600RF is a stationary X-ray flat panel detector (FPD) used to capture X-ray images for general radiographic diagnosis. It intercepts X-ray photons using a GOS scintillator, which emits visible light onto an amorphous silicon (a-Si) thin-film transistor (TFT) array to generate electrical signals. These signals are digitized and transmitted via Gigabit Ethernet to a connected computer and operator console (DROC). The device is operated by trained healthcare professionals (radiographers/technicians) in clinical settings. It does not control the X-ray generator. By replacing traditional film/screen systems, it enables digital image acquisition, storage, and display, facilitating faster diagnostic workflows and potentially reducing patient radiation exposure through improved detector sensitivity.

Clinical Evidence

Bench testing only. Performance evaluated via non-clinical studies including Detective Quantum Efficiency (DQE), Modulation Transfer Function (MTF), sensitivity linearity, lag, uniformity, noise power spectrum (NPS), spatial resolution, and image acquisition time. Electrical, mechanical, and environmental safety verified per IEC/ES 60601-1; EMC testing per IEC/EN 60601-1-2. No clinical data presented.

Technological Characteristics

GOS scintillator; a-Si TFT readout; 5632 x 2816 pixel matrix; 154μm pixel pitch; 16-bit grayscale; 3.4 lp/mm spatial resolution; Gigabit Ethernet connectivity; air cooling; carbon fiber plate housing; dimensions 916.9mm x 486.4mm x 42.8mm. Operates with external X-ray generator sync.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in general-purpose procedures. Not for mammography. Suitable for all patient populations requiring general X-ray imaging.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Mars1417V-PSI Wireless Digital Flat Panel Detector (K161730)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

CareRay Digital Medical Tehnology Co., Ltd. % Leilei Li RA Manager A2-201/B3-501, Biobay, 218 Xinghu Street SuZhou Industrial Park Suzhou, Jiangsu 215123 CHINA

February 19, 2021

#### Re: K202995

Trade/Device Name: X-ray Flat Panel Detectors/CareView 3600RF Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: January 15, 2021 Received: January 22, 2021

Dear Leilei Li:

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

{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 ([e-mail]) or phone [phone] 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) K202995

Device Name X-ray Flat Panel Detectors/CareView 3600RF

Indications for Use (Describe)

The CareView 3600RF detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purposic procedures. This product is not intended for mammography applications.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <span style="font-size:100%;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size:100%;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 006_510(k) Summary

{4}------------------------------------------------

## 510(k) Summary

[As required by 21 CFR 807.92]

## 1. Date Prepared [21 CFR807.92 (a) (1)]

Sep. 28, 2020

## 2. Submitter's Information [21 CFR807.92 (a) (1)]

| Company Name: | CareRay Digital Medical Technology Co., Ltd. | |
|------------------|-------------------------------------------------------------------------------------------------|--|
| Company Address: | A2-201/B3-501, Biobay, 218 Xinghu Street, Suzhou<br>Industrial Park, Suzhou 215123, P. R. China | |
| Contact Person: | Ms. Li | |
| Phone Number: | (86) 512-86860288 | |
| Fax Number: | (86) 512-86860388 | |
| E-mail: | [e-mail] | |

#### 3. Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]

| Trade Name: | X-ray Flat Panel Detectors |
|----------------------|----------------------------|
| Model Name: | CareView 3600RF |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB |

### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicates within this submission are as follows:

| Manufacturer: | iRay Technology (Shanghai) Ltd. |
|----------------------|--------------------------------------|
| Trade Name: | Wireless Digital Flat Panel Detector |
| Model Name: | Mars1417V-PSI |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |

{5}------------------------------------------------

| Regulatory Class: | Class II |
|-------------------|----------|
| Product Code: | MQB |
| FDA 510(k) #: | K161730 |

#### 5. Description of the Device [21 CFR 807.92(a)(4)]

The CareView 3600RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 867.5mm×433.1mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode).

The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.

The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device.

### 6. Intended Use [21 CFR 807.92(a)(5)]

The CareView 3600RF detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.

| Item | Proposed Device:<br>X-ray Flat Panel Detectors | Predicate Device:<br>Wireless Digital Flat Panel<br>Detector | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | To be assigned | K161730 | | |
| Model | CareView 3600RF | Mars1417V-PSI | | |
| Intended Use | The CareView 3600RF detector<br>is indicated for digital imaging<br>solution designed for providing<br>general radiographic diagnosis of<br>human anatomy. It is intended to<br>replace radiographic film/screen<br>systems in all general-purpose<br>diagnostic procedures. This<br>product is not intended for<br>mammography applications. | Mars1417V-PSI Wireless Digital<br>Flat Panel Detector is indicated for<br>digital imaging solution designed for<br>providing general radiographic<br>diagnosis of human anatomy. It is<br>intended to replace radiographic<br>film/screen systems in all<br>general-purpose diagnostic<br>procedures. This product is not<br>intended for mammography or<br>dental applications. | | |
| Classification<br>Name | Stationary X-ray system | Stationary X-ray system | | |
| Product Code | MQB | MQB | | |
| Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 | | |
| Panel | Radiology | Radiology | | |
| Class | II | II | | |
| X-ray Absorber | GOS Scintillator | GOS Scintillator | | |
| Installation Type | Wired | Wireless, Portable | | |
| Readout<br>Mechanism | Thin Film Transistor | Thin Film Transistor | | |
| Image Matrix Size | 5632 x 2816 pixels | 2304 x 2800 pixels | | |
| Pixel Pitch | 154μm | 150μm | | |
| Effective Imaging<br>Area | 867.5 mm x 433.1 mm | 355 mm x 434 mm | | |
| Grayscale | 16 bit | 14 bit | | |
| Spatial Resolution | 3.4 lp/mm | 3.4 lp/mm | | |
| MTF | 75%..........(@ 0.5lp/mm)<br>50%..........(@ 1lp/mm) | 0.75..........(@ 0.5lp/mm) | | |
| DQE | (@RQA5, 3.2µGy)<br>28%..........(@ 0.5lp/mm)<br>20%..........(@ 1lp/mm) | (@RQA5, 3.2µGy)<br>0.27..........(@ 0.5lp/mm) | | |
| Power<br>Consumption | ~50W | Max. 13W | | |
| Communications | Gigabit Ethernet | Wired: Gigabit Ethernet<br>Wireless: IEEE 802.11a/b/g/n<br>(2.4 GHz/ 5 GHz) | | |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate | | |
| Cooling | Air cooling | Air cooling | | |
| Dimensions | 916.9mm x 486.4mm x 42.8mm | 384mm x 460mm x 15mm | | |
| Operation | Temperature: +10 ~ +40°C<br>Humidity: 30 ~ 75% RH<br>(Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa<br>Altitude: Max. 3000 meters | Temperature: +5 ~ +35°C<br>Humidity: 30 ~ 75% RH<br>(Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa<br>Altitude: Max. 3000 meters | | |
| | Storage and<br>transportation | Temperature: -20 ~ +55°C<br>Humidity: 10 ~ 90% RH<br>(Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa<br>Altitude: Max. 3000 meters | Temperature: -20 ~ +55°C<br>Humidity: 10 ~ 90% RH<br>(Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa<br> | |
| | | Software | CareRay software provides a set<br>of predefined APIs (Application<br>Programming Interfaces), an<br>adapter layer between a<br>CareView 3600RF detector and<br>an upstream program on the<br>client side, commonly known as<br>DROC (Digital Radiography<br>Operator Console).<br>DROC communicates with the<br>CareRay detectors via APIs. In | iRay DR<br>The iRay DR used for getting Digital<br>X-ray radiography images from the<br>flat panel detectors. iRay DR is<br>used to handle the DICOM protocol<br>(DICOM 3.0),<br>iRay DR is responsible for the DR<br>equipment management,<br>acquisition and processing<br>functions to provides patient |
| | | | | general, APIs are provided in the<br>form of DLL (Dynamic-Link<br>Libraries) files. The upstream<br>program imports these DLL files<br>and calls relevant API<br>commands to manipulate a<br>CareView 3600RF<br>detector—query status, select<br>application mode, calibrate<br>detector, acquire images, and<br>preprocess images—without<br>caring about the implementation<br>details of the algorithm or<br>workflow under the hood. |
| Utilized FDA<br>guidance<br>documents | 1. Guidance for the Submission<br>of 510(k)s for Solid State<br>X-ray Imaging Devices<br>2. The 510(k) Program:<br>Evaluating Substantial<br>Equivalence in Premarket<br>Notifications[510(k)]<br>3. Pediatric Information for<br>X-ray Imaging Device<br>Premarket Notifications<br>4. Guidance for the Content of<br>Premarket Submissions for<br>Software Contained in<br>Medical Devices<br>5. Content of Premarket<br>Submissions for<br>Management of<br>Cybersecurity in Medical<br>Devices | | 1. Guidance for the Submission of<br>510(k)s for Solid State X-ray<br>Imaging Devices<br>2. The 510(k) Program: Evaluating<br>Substantial Equivalence in<br>Premarket Notifications[510(k)]<br>3. Pediatric Information for X-ray<br>Imaging Device Premarket<br>Notifications<br>4. Radio Frequency Wireless<br>Technology in Medical devices<br>5. Guidance for the Content of<br>Premarket Submissions for<br>Software Contained in Medical<br>Devices<br>6. Content of Premarket<br>Submissions for Management<br>of Cybersecurity in Medical<br>Devices | |

### 7. Technological Characteristics [21 CFR 807.92(a)(6)]

{6}------------------------------------------------

{7}------------------------------------------------

## 8. System requirements to operate with other radiographic system components

The submitted medical device is the CareView 3600RF digital detector. The other x-ray system components referred below are for information purpose only.

1) Recommended Generator Specification:

Energy range: 40~150kVp

mA range: 10~1000mA (depending on the generator power)

ms range: 10~6300ms to produce 0.1~1000mAs (depending on the generator power)

Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have questions regarding the compatibility issue for

{8}------------------------------------------------

other generators, please contact your distributor or CareRay.

- 2) Application Program Interface (API) for system integration manufacturer Peripheral hardware: CareView detector connected via wired communication. CPU: Intel (R) Core (TM) 2 Duo, 2.93GHz or above RAM: 6 GB or higher Hard disk: 80 GB or higher Monitor: 1280 x 1024 or higher OS: Windows 7 or Windows 10 Development environment: MS Visual Studio 2005 3) X-ray exposure mode
The synchronous connection mode is the signal transfer mode between the X-ray generator which sends the X-ray and the detector which receives the X-ray.

CareView 3600RF supported typical sync mode contains external sync mode.

The detector can't provide feedback to the generator to terminate the x-ray exposure.

#### 9. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92(b)(2)]

- A Electrical safety and EMC testing
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC/EN 60601-1-2. All test results are satisfactory.

- Nonclinical and clinical considerations A
The non-clinical studies have been performed and the results have shown that the CareView 3600RF X-ray flat panel detectors is substantially equivalent to the predicate device on the market (Mars1417V-PSI Wireless Digital Flat Panel Detector, K161730):

Detective quantum efficiency (DQE). Quantum limited performance, Modulation transfer function (MTF), Effects of aliasing, Sensitivity linearity, Lag(Erasure thoroughness), Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Image Acquisition time, & Black level

#### 10. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the CareView 3600RF X-ray flat panel detector is substantially equivalent to predicate device Mars1417V-PSI Wireless

{9}------------------------------------------------

Digital Flat Panel Detector (K161730). Both propose and predicate devices are same in the intended use, the design principle and the applicable standards. Therefore, CareRay Digital Medical Technology Co., Ltd. concludes the CareView 3600RF X-ray flat panel detector is substantially equivalent with the predicate device with regard to safety and effectiveness..