Digital Intraoral X-Ray Sensor

K230811 · Iray Imaging Technology (Haining) Limited · MUH · Apr 21, 2023 · Dental

Device Facts

• Record ID: K230811
• Device Name: Digital Intraoral X-Ray Sensor
• Applicant: Iray Imaging Technology (Haining) Limited
• Product Code: MUH · Dental
• Decision Date: Apr 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

Used in conjunction with a pulsed dental X-ray machine, the CS 6200 is intended for medical institutions to perform static digital X-ray imaging facilitating the diagnosis of the teeth, jaw, mouth, and other structural diseases.

Device Story

USB-driven digital intraoral X-ray sensor; CMOS technology; acquires real-time dental diagnostic images. Input: X-ray radiation detected via internal trigger module (AED) during pulsed dental X-ray machine exposure. Transformation: CMOS photodiode array converts X-rays to digital image data; transmitted via USB 2.0 to external workstation. Output: Static digital X-ray images displayed on workstation for clinical diagnosis. Used in dental clinics/medical institutions by dentists/technicians. Benefits: Facilitates diagnosis of dental/jaw/mouth structural diseases. No onboard software; relies on external workstation for image processing/display.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (IEC 60601-2-65). Biological evaluation conducted per ISO 10993-1. Bench metrics compared to predicate include dose-to-output signal transfer, SNR, uniformity, MTF, spatial resolution, and low contrast resolution.

Technological Characteristics

CMOS photodiode array detector; CsI scintillator; USB 2.0 interface. Dimensions: 23.4mm x 33.6mm x 4.5mm. Pixel pitch: 20μm. ADC: 16-bit. Spatial resolution: Max 25lp/mm. Protection: IP68. Power: DC 5V, 400mA. Air cooling. Type BF electrical protection. Standards: IEC 60601-1, IEC 60601-2-65, IEC 60601-1-2, ISO 10993-1.

Indications for Use

Indicated for medical institutions to perform static digital X-ray imaging of teeth, jaw, mouth, and structural diseases. Intended for use by trained dentists, dental technicians, and maintenance personnel. Contraindicated for mammography, dynamic imaging, and pregnant women.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• PlutoX Digital Intraoral X-Ray Imaging System (K210312)

Submission Summary (Full Text)

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April 21, 2023

iRay Imaging Technology (Haining) Limited % Jeffrey Wu Registration & Regulation Affairs Engineer No. 2. Caohejing RD., Haining 314499, Jiaxing Zheiiang, P.R.China Haining, Zhejiang 314499 CHINA

Re: K230811

Trade/Device Name: Digital Intraoral X-Ray Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: March 20, 2023 Received: March 24, 2023

Dear Jeffrey Wu:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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)

K230811

Device Name Digital Intraoral X-Ray Sensor

Indications for Use (Describe)

Used in conjunction with a pulsed dental X-ray machine, the CS 6200 is intended for medical institutions to perform static digital X-ray imaging facilitating the diagnosis of the teeth, jaw, mouth, and other structural diseases.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## iRay Imaging Technology (Haining) Limited

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

(As Required by 21 CFR 807.92)

### 1. Date Prepared [21 CFR 807.92(a)(1)]

March 05, 2023

### 2. Submitters Information [21 CFR 807.92(a)(1)]

| Company Name: | iRay Imaging Technology (Haining) Limited |
|------------------|-----------------------------------------------------------------------|
| Company Address: | No. 2, Caohejing RD., Haining 314499, Jiaxing, Zhejiang,<br>P.R.China |
| Contact Person: | Jeffrey Wu |
| Phone: | 86-21-50720539 |
| Fax: | 86-21-50720561 |
| Email: | [e-mail] |

### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | Digital Intraoral X-Ray Sensor |
|----------------------|--------------------------------|
| Common Name: | Extraoral Source X-Ray System |
| Model Name: | CS 6200 |
| Classification Name: | Extraoral Source X-Ray System |
| Product Code: | MUH |
| Regulation Number: | 21 CFR 872.1800 |
| Device Class: | Class II |

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

The identification predicates within this submission are as follows:

| Manufacturer: | iRay Technology Co., Ltd. |
|---------------|-----------------------------------------------|
| Trade Name: | PlutoX Digital Intraoral X-Ray Imaging System |
| Model Name: | Pluto0001X, Pluto0002X |
| Product Code: | MUH |

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#### [510(k)] Application iRay Imaging Technology (Haining) Limited

Classification Name: Extraoral Source X-Ray System FDA 510 (k) #: K210312

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

The CS 6200 is a USB-driven digital intraoral X-ray sensor based on CMOS technology that is specially designed for acquiring real-time high-quality dental diagnostic images. Image data acquired from the device can be transmitted via a USB 2.0 port to a workstation for display and processing.

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

### 6.1. Indications for use

Used in conjunction with a pulsed dental X-ray machine, the CS 6200 is intended for medical institutions to perform static digital X-ray imaging facilitating the diagnosis of the teeth, jaw, mouth, and other structural diseases.

### 6.2. Suitable patient

The device is intended for use by trained and qualified dentists, dental technicians, and maintenance personnel.

It is not suitable for mammography and dynamic imaging photography. Do not use it on pregnant women.

### 6.3. Processing of input and output

When sensor works continuously, it can automatically distinguish X-ray and output an imaging for diagnosis of disease, injury, or of any applicable health problem.

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

| Item | Predicate Device:<br>Digital Intraoral X-Ray Imaging<br>System | Proposed Device:<br>Digital Intraoral X-Ray Sensor |
|------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------|
| Model Name: | Pluto0001X<br>Pluto0002X | CS 6200 |
| 510(K) Number: | K210312 | To be determined |
| Classification | Extraoral Source X-ray System | Same |
| Item | Predicate Device:<br>Digital Intraoral X-Ray Imaging<br>System | Proposed Device:<br>Digital Intraoral X-Ray Sensor |
| Name: | | |
| Product Code : | MUH | Same |
| Regulation Number: | 21 CFR 872.1800 | Same |
| Panel: | Radiology | Same |
| Classification: | II | Same |
| X-Ray Absorber<br>(Scintillator): | CsI | Same |
| Installation Type: | Portable | Same |
| Degree of protection<br>against electrical<br>shock: | Type BF | Same |
| Detector structure: | CMOS Photodiode Array | Same |
| Power Consumption: | DC 5V, 400mA | Same |
| Dimensions: | Pluto0001X:<br>38.5mm×25mm×4.5mm<br>Pluto0002X:<br>40mm×31mm×4.5mm | 23.4mm×33.6mm×4.5mm |
| Image Matrix Size: | 1500 × 1000 pixels for<br>Pluto0001X<br>1800 × 1300 pixels for<br>Pluto0002X | 900 × 1200 pixels |
| Pixel Pitch: | 20μm | Same |
| Effective Imaging<br>Area: | 30mm × 20mm for Pluto0001X;<br>36mm × 26mm for Pluto0002X; | 18mm × 24mm |
| ADC<br>Digitization: | 16 bit | Same |
| Spatial Resolution: | Max 25lp/mm | Max 25lp/mm |
| Modulation<br>Transfer<br>Function (MTF): | 10% at 12.5 lp/mm | 10% at 8.0 lp/mm |
| Communications: | USB 2.0 | Same |
| Cooling: | Air cooling | Same |
| Protection<br>against<br>matter/Water | IP68 | Same |
| Operation: | Temperature: 10 to 35°C | Temperature: 10 to 35°C |
| Item | Predicate Device:<br>Digital Intraoral X-Ray Imaging<br>System | Proposed Device:<br>Digital Intraoral X-Ray Sensor |
| | Humidity: 20 to 90% (Non- | Humidity: 5 to 95% (Non- |
| | Condensing) | Condensing) |
| | Atmospheric pressure: 70 to 106 | Atmospheric pressure: 70 to 106 |
| | kPa | kPa |
| | Altitude: Max. 3000 meters | Altitude: Max. 3000 meters |
| | Storage and<br>Transportation: | Temperature: -10 °C ~ 55 °C |
| Humidity: 10% ~ 95% | | Humidity: 5% ~ 95% |
| (Non-Condensing) | | (Non-Condensing) |
| Atmospheric pressure: | | Atmospheric pressure: |
| 70kPa~106kPa | | 70kPa~106kPa |
| Altitude: Max. 3000 meters | | Altitude: Max. 3000 meters |
| Software: | iRayDR | No accompanying software |

# SECTION 6 - 3 of 7

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iRay Imaging Technology (Haining) Limited

## [510(k)] Application

# SECTION 6 - 4 of 7

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iRay Imaging Technology (Haining) Limited

[510(k)] Application

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

- 1) Recommended Generator Specification:
Energy range: 55~100kV

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 sensor is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact your distributor or iRay's service office.

- 2) Application Program Interface (API) for system integration manufacturer Peripheral hardware: CS 6200 connected via USB 2.0 communication.

| Operating System: | Windows 7 64bit, or even higher |
|-------------------|---------------------------------------------------------|
| CPU: | Inter(R) Celeron N3450 frequency≥1.5GHz, or even higher |
| Memory: | 8G DDR3 or higher |
| Hard Disk: | 500 G or higher |
| Port: | USB 2.0 |

# SECTION 6 - 5 of 7

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#### iRay Imaging Technology (Haining) Limited [510(k)] Application

Display setting: 1278 × 768

- 3) X-ray exposure mode
The AED module can connect X-ray signal in the CS 6200. Once there is X-ray generator exposure exist, the inner trigger module will detect the X-ray radiation and output signal to the detector. Until the exposure finished, the detector will receive a signal which represent the end of exposure from the inner trigger module and begin to acquire the image.

### 9. Nonclinical study

- Electrical Safety and EMC testing: 1)
Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 and IEC60601-2-65 were performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.

- 2) Biological Evaluation:
Although there is a single-use protective sheeth prior to each use, the materials of the intra-oral sensor enclosure which may contact patient's oral mucosa have been evaluated with the ISO10993-1. And the evaluation results and test result assured the safety the same as the predicate device.

- 3) Nonclinical Considerations:
According to the Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices, the non-clinical studies have been performed and the results have shown that the CS 6200 are substantially equivalent to the predicate devices on the Market (K210312):

Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time. In addition, the propose device does not include software, so it will not affect the

safety and effectiveness.

- 4) Clinical Consideration:
Clinical data is not needed to characterize performance and establish substantial

# SECTION 6 - 6 of 7

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#### iRay Imaging Technology (Haining) Limited [510(k)] Application

equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles.

### 10. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, manufacturer concludes that CS 6200 is substantially equivalent to predicate device with regards to safety and effectiveness.

# SECTION 6 - 7 of 7