Portable X-ray System Model Ray98(P)

K231449 · Ningbo Runyes Medical Instrument Co., Ltd. · EHD · Jul 13, 2023 · Dental

Device Facts

• Record ID: K231449
• Device Name: Portable X-ray System Model Ray98(P)
• Applicant: Ningbo Runyes Medical Instrument Co., Ltd.
• Product Code: EHD · Dental
• Decision Date: Jul 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended as extraoral x-ray source to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

Device Story

Portable X-ray system for dental radiographic examination; produces ionizing radiation to expose intra-oral receptors (analog film, digital phosphorous plates, digital sensors). Device includes internal timer to control exposure duration. Used in general dentistry, particularly for special needs or nursing home patients where mobility is limited. Operated by dentists or dental technicians. User interface features LCD display with up-down buttons for exposure time selection, plus presets for patient size and tooth selection. Output is diagnostic X-ray image captured on external receptor. Benefits include portability and utility in diverse clinical settings.

Clinical Evidence

Bench testing only. Performance data includes electrical safety, EMC, software validation, usability, and risk assessment conducted per IEC/ISO standards (e.g., IEC 60601-1, 60601-2-65, 62304). No clinical data provided.

Technological Characteristics

Portable dental X-ray system; 70kVp, 2mA, constant potential (DC) generator. 0.4mm focal spot; 1.5mmAl total filtration; 1.6mm Al HVL. Source-to-skin distance 20.5cm. Battery-powered. User interface: LCD with preset exposure times. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 60601-2-65, IEC 62304, IEC 62366, ISO 14971.

Indications for Use

Indicated for use by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors in both adult and pediatric subjects.

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

• MobileX Portable X-ray System (Model T-100) (K180561)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and arranged in three lines.

July 13, 2023

Ningbo Runyes Medical Instrument Co., Ltd. % W. Lee Strong Quality Systems Manager 510K FDA Inc. 156 E Granada Blvd. ORMOND BEACH FL 32176

Re: K231449

Trade/Device Name: Portable X-ray System Model Ray98(P) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: May 16, 2023 Received: May 18, 2023

Dear W. Lee Strong:

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 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,

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) K231449

Device Name Portable X-ray System Model Ray98(P)

Indications for Use (Describe)

The device is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

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

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Image /page/3/Picture/0 description: The image shows a stylized black and white drawing of a bird's head and wing. The wing is large and prominent, with several distinct feathers. The bird's head is facing to the right and has a sharp beak. The overall design is simple yet elegant, suggesting a logo or emblem.

# 510k FDA Consulting

K231449

Medical Device Clearances

156 East Granada Blvd.

Ormond Beach, FL 32176

386-506-8711

# 510(k) Summary

#### Submitter/Applicant

Ningbo Runyes Medical Instrument Co., Ltd. No. 456 Tonghui Road Jiangbei Investment & Pioneering Park C Ningbo Zhejiang, CN 315000

Phone: + 86-574-27709922 Weiqiong Fang, Registration Dept ([e-mail]) Contact:

Date Prepared: July 13, 2023

#### Preparer/Consultant

510K FDA Inc. 156 East Granada Blvd. Ormond Beach, FL 32176

Phone: [phone]

Fax: [phone] Primary Contact: Lee Strong, Regulatory Dept. Mgr (lee(@510kfda.com) Secondary Contacts: Claude Berthoin, CEO (claude(@denterpriseintl.com).

#### Device Classification

| Trade/Model Names: | Portable X-ray System Model Ray98(P) |
|-----------------------|--------------------------------------|
| Common Name: | Portable X-ray System |
| Regulation Name: | Extra-oral Source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Primary Product Code: | EHD |
| Classification Name: | Unit, X-ray, Extraoral with Timer |
| Regulatory Class: | II |

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510k Review Panel: Dental

#### Predicate Device

The subject device claims equivalence to the following legally marketed predicate:

| 510(k) Number: | K180561 |
|-----------------------|---------------------------------------------|
| Applicant: | Denterprise International, Inc. |
| Date Cleared: | April 4, 2018 |
| Trade Name: | MobileX Portable X-ray System (Model T-100) |
| Regulation Name: | Extra-oral Source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Primary Product Code: | EHD |
| Classification Name: | Unit, X-ray, Extraoral with Timer |
| Regulatory Class: | II |
| 510k Review Panel: | Dental |

#### Indications for Use

The device is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

#### Intended Use

Intended as extraoral x-ray source to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

#### Device Description

The Ray98(P) by Ningbo Runyes Medical Instrument Co., Ltd., is a portable x-ray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.

The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the portable device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.

This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The portable x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.

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# Comparison of Technological Characteristics with Predicate

The following table compares technological and other characteristics of the subject and predicate device.

| Device<br>Characteristic | Subject Device<br>Portable X-ray System<br>Model Ray98(P) | Predicate Device Mobile-X<br>Portable X-ray System<br>(K180561) | Comparison |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510(k) Owner | Ningbo Runyes Medical<br>Instrument Co., Ltd. (China) | Denterprise International,<br>Inc.<br>(USA) | NA |
| Classification &<br>Product Code | 872.1800; EHD | 872.1800; EHD | Similar |
| Intended Use | Intended as extraoral x-ray<br>sources to be used with<br>intraoral image receptors for<br>diagnostic imaging by<br>dentists or dental technicians. | Intended as extraoral x-ray<br>sources to be used with<br>intraoral image receptors for<br>diagnostic imaging by<br>dentists or dental technicians. | Similar |
| Indication for Use | The device is a diagnostic X-<br>ray system which is intended<br>to be used by trained dentists<br>and dental technicians as an<br>extra-oral X-ray source for<br>producing diagnostic x-ray<br>images using intra-oral<br>receptors. Its use is intended<br>for both adults and pediatric<br>subjects. | The device is a diagnostic X-<br>ray system, which is<br>intended to be used by<br>trained dentists and dental<br>technicians as an extra-oral<br>X-ray source for producing<br>diagnostic x-ray images<br>using intra-oral receptors. Its<br>use is intended for both<br>adults and pediatric subjects. | Similar |
| Size | 5.75" x 6.0" x 9.5" | 6.5" x 6.0" x 10.5" | Difference of<br>design, size |
| Source to Skin<br>Distance | $20.5 cm ±0.5cm$ | $20.5 cm$ | Difference .5<br>cm |
| Cone diameter | $6.0 cm ±0.5cm$ | $6.0 cm$ | Difference<br>±0.5cm |
| Device<br>Characteristic | Subject Device<br>Portable X-ray System<br>Model Ray98(P) | Predicate Device Mobile-X<br>Portable X-ray System<br>(K180561) | Comparison |
| User interface | Up-down buttons for<br>exposure time selection with<br>timer display. Additionally,<br>several user-selectable preset<br>times with patient size, and<br>tooth selection icons on an<br>LCD display. | Up-down buttons for<br>exposure time selection with<br>timer display. Additionally,<br>several user-selectable preset<br>times with patient size,<br>image-receptor type, and<br>tooth selection icons on an<br>LCD display. | Difference;<br>subject device<br>does not set<br>image-receptor<br>type |
| Exposure switch | Exposure button at front<br>cover on right hand side or<br>remote switch. | Exposure button at front<br>cover on right hand side or<br>remote switch. | Similar |
| Electrical<br>Information | | | |
| Exposure time | 0.04 ~ 2.0 seconds in fixed<br>increments:<br>0.04s, 0.05s, 0.06s, 0.08s,<br>0.10s, 0.12s, 0.16s, 0.20s,<br>0.25s, 0.32s, 0.40s, 0.50s,<br>0.63s, 0.80s, 1.00s, 1.25s,<br>1.60s, 2.00s | 0.01 ~ 1.3 seconds in 0.01<br>or 0.05 increments | Difference;<br>subject device<br>has higher<br>exposure time<br>limits and fixed<br>increments |
| Time accuracy | ± (10% +1 ms) | ± (10% +1 ms) | Similar |
| mA | 2mA | 2mA | Similar |
| kVp | 70kVp | 70kVp | Similar |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Similar |
| Total Filtration | 1.5mmAl | 1.5mmAl | Similar |
| Half-Value Layer<br>(HVL) | 1.6mm Al | 1.5mm Al | Difference;<br>subject device<br>has higher<br>HVL |
| X-ray Focal Spot | 0.4mm | 0.4mm | Similar |
| Device<br>Characteristic | Subject Device<br>Portable X-ray System<br>Model Ray98(P) | Predicate Device Mobile-X<br>Portable X-ray System<br>(K180561) | Comparison |
| Average Number of<br>0.5s Exposures with<br>Fully Charged<br>Battery | 500 | 400 | Difference;<br>subject device<br>has higher<br>average<br>exposures |
| Performance<br>standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-65<br>IEC 62304<br>IEC 62366<br>ISO 14971 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-3<br>IEC 60601-1-6<br>IEC 60601-2-65<br>IEC 62304<br>IEC 62366<br>ISO 14971 | Similar |

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The above comparison shows the subject and predicate devices have substantially similar technological characteristics. Differences show up in the shape, size, design of the device and those are in cm and mm measurements of slight difference. The differences of the device are minor and do not raise new issues of safety and effectiveness.

## Non-Clinical Performance Data

The following performance testing was completed on the subject device in support of the substantial equivalence determination of the predicate device.

- Electrical Safety and EMC ●
- Software Validation ●
- Usability .
- Clinical Evaluation ●
- Risk Assessment ●
- . All tests were performed in accordance with IEC and ISO standards and tests are recognized by FDA.
- None of the standards were adapted for application to the device under review. ●
- No deviations from the standards were applied.
- No differences exist between the tested device and the device to be marketed. ●
- . Conformity with all standards was determined by the device manufacturer, Ningbo Runyes Ltd., Korea.

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- Electrical test performed by KCTL, Inc. Laboratories, Inc., Korea. ●
# Specific Guidance Document

The Guidance document: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices applies to this device. Details of this guidance are provided within the Software Validation Report.

# Labels

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

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

# Substantial Equivalence

The above comparison chart shows the subject and predicate devices have similar technological characteristics.

Both devices have:

- Similar function and are used in similar environments. ●
- The same indications for use and the same intended use. ●
- Similar manufacturing process and similar technological characteristics. ●
- Both devices have completed similar IEC and ISO standardized testing listed in the ● comparison chart shown above.

## Conclusion

The subject and predicate device have the same indications for use, the same intended use and similar technological characteristics. The Portable X-ray System Model Ray98(P) performs similar functions, in a similar environment as the predicate device. Portable X-ray System Model Ray98(P) uses similar technology as the predicate device, based on well-known technology. Portable X-ray System Model Ray98(P) is as safe and effective as the predicate device. We believe the subject device does not introduce any new safety concerns and is substantially equivalent to the predicate device. In conclusion, the subject device, Portable Xrav System Model Ray98(P), is at least as safe and effective as the predicate device and warrants a finding of substantial equivalence to the legally marketed device.