X-ray Flat Panel Detectors (CareView 1800 RF)

K221549 · Careray Digital Medical Technology Co., Ltd. · MQB · Aug 1, 2022 · Radiology

Device Facts

• Record ID: K221549
• Device Name: X-ray Flat Panel Detectors (CareView 1800 RF)
• Applicant: Careray Digital Medical Technology Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Aug 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The CareView 1800RF 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 1800RF is a stationary X-ray flat panel detector (FPD) used for general radiographic and dynamic (fluoroscopic) imaging. The device intercepts X-ray photons using a CsI scintillator, which emits visible light captured by an amorphous silicon (a-Si) thin-film transistor (TFT) array. This array converts light into electrical signals, which are then digitized and transmitted via Gigabit Ethernet to a connected computer for image display. The device is operated by clinical staff in a diagnostic setting. It integrates with an external X-ray generator and a workstation. The output provides digital radiographic images to assist clinicians in diagnostic decision-making. The device benefits patients by enabling digital imaging, replacing traditional film/screen systems.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through electrical, mechanical, and environmental safety testing per IEC/ES 60601-1 and EMC testing per IEC/EN 60601-1-2.

Technological Characteristics

CsI scintillator; a-Si TFT readout; 434mm x 434mm imaging area; 154µm pixel pitch; 16-bit grayscale; Gigabit Ethernet connectivity; air-cooled; 24V DC power; wired cassette form factor. Standards: IEC/ES 60601-1, IEC/EN 60601-1-2.

Indications for Use

Indicated for digital radiographic diagnosis of human anatomy in general-purpose diagnostic procedures. Not for mammography.

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

• CareView 1800Le (K193173)

Reference Devices

• Digital Flat Panel X-ray Detector 1717FCC (K210985)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has a blue square with the letters FDA in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 5, 2022

CareRay Digital Medical Technology Co., Ltd. % Xu Wei Manager A2-201/B3-501, Biobay,218 Xinghu Street, SuZhou Industrial Park, Suzhou, Jiangsu 215123 CHINA

Re: K221549

Trade/Device Name: X-ray Flat Panel Detectors (CareView 1800 RF) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, JAA

Dear Xu Wei:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 01, 2022. Specifically, FDA is updating this SE Letter as an administrative correction due to an omission of the secondary product code JAA.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laurel Burk, OHT8: Office of In Vitro Diagnostics and Radiological Health, telephone [phone], Laurel.Burk(@fda.hhs.gov

Sincerely,

Laurel M.
Burk -S

Laurel Burk, 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

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

August 1, 2022

CareRay Digital Medical Technology Co., Ltd. % Xu Wei Manager A2-201/B3-501, Biobay,218 Xinghu Street, SuZhou Industrial Park, Suzhou, Jiangsu 215123 CHINA

Re: K221549

Trade/Device Name: X-ray Flat Panel Detectors (CareView 1800 RF) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: May 27, 2022 Received: June 7, 2022

Dear Xu Wei:

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

{2}------------------------------------------------

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(@tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Laurel M. Burk -S
2022.08.01
09:56:48 -04'00'

Laurel Burk, 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

Enclosure

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

#### Indications for Use

510(k) Number (if known) K221549

Device Name

X-ray Flat Panel Detectors (CareView 1800RF)

Indications for Use (Describe)

The CareView 1800RF 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

#### 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."

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

# 510(k) Summary

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

# 510(k) Summary

#### K221549

[As required by 21 CFR 807.92]

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

Mar. 18, 2022

#### 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: | Mr. Xu | |
| 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 1800RF |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB,JAA |

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

The identified primary predicates within this submission are as follows: Manufacturer: CareRay Digital Medical Technology Co., Ltd. Trade Name: X-ray Flat Panel Detectors Model Name: CareView 1800Le

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

| Classification Name: | Stationary X-ray system |
|----------------------|-----------------------------------|
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB |
| FDA 510(k) #: | K193173 |
| Reference Device: | |
| Manufacturer: | Rayence Co., Ltd. |
| Trade Name: | Digital Flat Panel X-ray Detector |
| Model Name: | 1717FCC |
| Classification Name: | Stationary X-ray system |
| Regulation Number: | 21 CFR 892.1680 |
| Regulatory Class: | Class II |
| Product Code: | MQB,JAA |
| FDA 510(k) #: | K210985 |

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

The CareView 1800RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 434 mm × 434 mm. 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.

The CareView 1800RF detector can be used for dynamic imaging (fluoroscopy).

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

The CareView 1800RF 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.

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

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

#### Comparison with the predicate device

| Item | Proposed Device:<br>X-ray Flat Panel Detectors | Predicate Device:<br>X-ray Flat Panel Detectors |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K221549 | K193173 |
| Model | CareView 1800RF | CareView 1800Le |
| Intended Use | The CareView 1800RF detector is<br>indicated for digital imaging solution<br>designed for providing general<br>radiographic diagnosis of human<br>anatomy. It is intended to replace<br>radiographic film/screen systems in all<br>general-purpose diagnostic procedures.<br>This product is not intended for<br>mammography applications. | The CareView 1800Le detector<br>is indicated for digital imaging<br>solution designed for providing<br>general radiographic diagnosis<br>of human anatomy. It is intended<br>to replace radiographic<br>film/screen systems in all<br>general-purpose diagnostic<br>procedures. This product is not<br>intended for mammography<br>applications. |
| Classification Name | Stationary X-ray system | Stationary X-ray system |
| Regulation Number | 892.1680 | 892.1680 |
| Panel | Radiology | Radiology |
| Class | II | II |
| X-ray Absorber | Csl Scintillator | Csl Scintillator |
| Installation Type | Wired, Cassette | Wired, Cassette |
| Readout<br>Mechanism | Thin Film Transistor | Thin Film Transistor |
| Image Matrix Size | 2816 × 2816 pixels | 3072 × 3072 pixels |
| Pixel Pitch | 154μm | 140μm |
| Effective Imaging<br>Area | 434 mm × 434 mm | 430 mm × 430 mm |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale |
| Spatial Resolution | 3.3 line pair/mm | 3.57 line pair/mm |
| MTF | ≥60%..........(@ 1lp/mm)<br>≥30%..........(@ 2lp/mm)<br>≥17%..........(@ 3lp/mm) | ≥63%..........(@ 1lp/mm)<br>≥35%..........(@ 2lp/mm)<br>≥17%..........(@ 3lp/mm) |
| DQE | (@RQA5, 2µGy)<br>≥55%..........(@ 1lp/mm)<br>≥20%..........(@ 3lp/mm) | (@RQA5, 30µGy)<br>≥62%..........(@ 1lp/mm)<br>≥45%..........(@ 1lp/mm)<br>≥17%..........(@ 3lp/mm) |
| Rated<br>Power<br>Supply | DC 24 V, Max.1.25 A | DC +24 V, Max.1 A |
| Network interface | Gigabit Ethernet | Gigabit Ethernet |
| Imaging Plate | Carbon Fiber Plate | Carbon Fiber Plate |
| Cooling | Air cooling | Air cooling |
| Dimensions | 460mm x 460mm x 28mm | 460 mm x 460 mm x 15 mm |
| Operation | Temperature: +10 ~ +40°C<br>Humidity: 30 ~ 75% (Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa | Temperature: +5 ~ +35°C<br>Humidity: 30 ~ 75% (Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa |
| Storage and<br>transportation | Temperature: -20 ~ +55°C<br>Humidity: 10 ~ 90% (Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa | Temperature: -20 ~ +55°C<br>Humidity: 10 ~ 90% (Non-Condensing)<br>Atmospheric pressure: 700 ~ 1060 hPa |
| Utilized<br>guidance<br>documents<br>FDA | 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 Software<br>Contained in Medical Devices<br>6. Content of Premarket Submissions<br>for Management of Cybersecurity in<br>Medical Devices | 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 |

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

#### Comparison with Reference Device

| Item | Proposed Device:<br>X-ray Flat Panel Detectors | Reference Device:<br>Digital Flat Panel X-ray Detector |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K221549 | K210985 |
| Model | CareView 1800RF | 1717FCC |
| | K221549 | K210985 |
| Intended Use | The CareView 1800RF 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. | 1717FCC is indicated for digital<br>imaging solution designed for<br>general radiographic system for<br>human anatomy.It is intended to<br>replace film or screen based<br>radiographic systems in all<br>general purpose diagnostic<br>procedures. Not to be used for<br>mammography. |
| Classification | Stationary X-ray system | Stationary X-ray system |

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

| Name | | |
|---------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MQB,JAA | MQB,JAA |
| Regulation Number | 21 CFR 892.1680 | 21 CFR 892.1680 |
| Panel | Radiology | Radiology |
| Class | II | II |
| X-ray Absorber | CsI Scintillator | CsI Scintillator |
| Detector Type | TFT | Amorphous Silicon (a-Si) TFT +<br>PIN type photodiode<br>IGZO TFT + PIN type photodiode |
| Image Matrix Size | 2816 x 2816 pixels | 3000 x 3000 pixels |
| Pixel Pitch | 154µm | 140µm |
| Effective Imaging<br>Area | 434 mm x 434 mm | 17 x 17 inches |
| Grayscale | 16 bit | 14/16 bit |
| Spatial Resolution | 3.3 lp/mm | 3.5 lp/mm |
| Pixel matrix | 154 μm: 2816×2816 (1x1 binning)<br>308 μ m: 1408×1408 (2x2 binning)<br>462 μ m: 896×896 (3x3 binning) | 140 type: 3000 x 3000 (Full resolution)<br>280 type: 1500 x 1500 (2x2 binning)<br>420 type: 1000 x 1000 (3x3 binning)<br>560 type: 750 x 750 (4x4 binning) |
| Frame rate | 4fps@2816×2816<br>15fps@1408×1408<br>25fps@896×896 | GigE<br>6 @ (1x1)<br>25 @ (2x2)<br>45 @ (3x3)<br>60 @ (4x4)<br>Camera link<br>9 @ (1x1)<br>30 @ (2x2)<br>45 @ (3x3)<br>60 @ (4x4)<br>5GigE<br>15 @ (1x1)<br>30 @ (2x2)<br>45 @ (3x3)<br>60 @ (4x4) |

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

The submitted medical device is the CareView 1800RF 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)

{10}------------------------------------------------

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 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 1800RF 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.

- A Nonclinical and clinical considerations
The proposed device (CareView 1800RF) and predicate device (CareView 1800Le) share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc.

The Intended Use, pixel matrix and frame rate for the proposed device CareView 1800RF is similar to the specification of the reference device 1717FC (K210985) .

- A Clinical images are not necessary for the current submission. Successful results of bench testing should be sufficient to show substantial equivalence for the subject device.
## 10. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the CareView 1800RF X-ray flat

{11}------------------------------------------------

panel detectors are substantially equivalent to predicate device CareView 1800Le X-ray flat panel detectors (K193173) and reference device(K210985). 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 1800RF X-ray flat panel detectors are substantially equivalent with the predicate device with regard to safety and effectiveness.