Diagnostic X-Ray Equipment Model POCT22

K252909 · Ningbo Runyes Medical Instrument Co., Ltd. · EHD · Feb 3, 2026 · Dental

Device Facts

• Record ID: K252909
• Device Name: Diagnostic X-Ray Equipment Model POCT22
• Applicant: Ningbo Runyes Medical Instrument Co., Ltd.
• Product Code: EHD · Dental
• Decision Date: Feb 3, 2026
• 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 dental X-ray system; generates ionizing radiation for radiographic examination of teeth, jaw, and oral structures. Device contains internal X-ray tube and timer; operator selects exposure parameters via LCD interface (patient size, tooth type) or manual up-down buttons. Used in general dentistry; assists with patients in nursing homes, special needs, or those with limited mobility. Compatible with analog film, digital phosphorous plates, and digital sensors. Output is X-ray exposure to receptor; clinician uses resulting image for diagnostic assessment of oral pathology. Benefits include portability for point-of-care imaging in non-traditional settings.

Clinical Evidence

No clinical data. Performance supported by bench testing, including electrical safety, EMC, software validation, usability, and risk assessment conducted in accordance with recognized IEC and ISO standards.

Technological Characteristics

Portable X-ray system; 70kVp, 2mA output; 0.4mm focal spot; 1.5mm Al total filtration; 1.6mm Al HVL. Constant potential (DC) waveform. Battery-powered. User interface: LCD with preset exposure times. Dimensions: 97 x 247 x 130mm. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 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 adult and pediatric patients.

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

• Portable X-ray System Model Ray98(P) (K231449)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

February 3, 2026

Ningbo Runyes Medical Instrument Co., Ltd.
% Lee Strong
Regulatory Consultant
510K FDA, Inc.
156 E. Granada Blvd.
ORMOND BEACH, FL 32176

Re: K252909
Trade/Device Name: Diagnostic X-Ray Equipment Model POCT22
Regulation Number: 21 CFR 872.1800
Regulation Name: Extraoral source x-ray system
Regulatory Class: Class II
Product Code: EHD
Dated: August 28, 2025
Received: January 14, 2026

Dear 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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252909 - Lee Strong
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252909 - Lee Strong
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assistance/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, 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)

K252909

Device Name

Diagnostic X-Ray Equipment Model POCT22

Indications for Use (Describe)

The Diagnostic X-Ray Equipment Model POCT22 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510k FDA Consulting
Medical Device Clearances
K252909
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: [phone]
Contact: Weiqiong Fang, Registration Dept ([e-mail])
Date Prepared: August 13, 2025

## Preparer/Consultant

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

Phone: [phone]
Fax: [phone]
Primary Contact: Lee Strong, Regulatory Dept. Mgr ([e-mail])
Secondary Contacts: Claude Berthoin, CEO ([e-mail]).

## Device Classification

Trade/Model Names: Diagnostic X-Ray Equipment Model POCT22
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
510k Review Panel: Dental

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# Predicate Device

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

510(k) Number: K231449
Applicant: Ningbo Runyes Medical Instrument Co., Ltd.
Date Cleared: July 13, 2023
Trade Name: Portable X-ray System Model Ray98(P)
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 Diagnostic X-Ray Equipment Model POCT22 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 Diagnostic X-Ray Equipment Model POCT22 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 and 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 Characteristic | Subject Device Diagnostic X-Ray Equipment Model POCT22 (K252909) | Predicate Device Portable X-ray System Model Ray98(P) (K231449) | Comparison |
| --- | --- | --- | --- |
| 510(k) Owner | Ningbo Runyes Medical Instrument Co., Ltd. (China) | Ningbo Runyes Medical Instrument Co., Ltd. (China) | NA |
| Classification & Product Code | 872.1800; EHD | 872.1800; EHD | Same |
| Intended Use | Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. | Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians. | Same |
| Indication for Use | The Diagnostic X-Ray Equipment Model POCT22 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. | 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. | Similar |
| Size | 97 x 247 x 130mm | 146 x 152 x 241mm | Difference of design, size |
| Source to Skin Distance | 20.5 cm ±0.5cm | 20.5 cm ±0.5cm | Same |
| Cone diameter | 6.0 cm ±0.5cm | 6.0 cm ±0.5cm | Same |

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| Device Characteristic | Subject Device Diagnostic X-Ray Equipment Model POCT22 (K252909) | Predicate Device Portable X-ray System Model Ray98(P) (K231449) | Comparison |
| --- | --- | --- | --- |
| User interface | Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size, and tooth selection icons on an LCD display. | Up-down buttons for exposure time selection with timer display. Additionally, several user-selectable preset times with patient size, and tooth selection icons on an LCD display. | Same |
| Exposure switch | Exposure button at front cover on right hand side or remote switch. | Exposure button at front cover on right hand side or remote switch. | Same |
| Electrical Information | | | |
| Exposure time | 0.04 ~ 2.0 seconds in fixed increments:
0.04s, 0.05s, 0.06s, 0.08s, 0.10s, 0.12s, 0.16s, 0.20s, 0.25s, 0.32s, 0.40s, 0.50s, 0.63s, 0.80s, 1.00s, 1.25s, 1.60s, 2.00s | 0.04 ~ 2.0 seconds in fixed increments:
0.04s, 0.05s, 0.06s, 0.08s, 0.10s, 0.12s, 0.16s, 0.20s, 0.25s, 0.32s, 0.40s, 0.50s, 0.63s, 0.80s, 1.00s, 1.25s, 1.60s, 2.00s | Same |
| Time accuracy | ± (10% +1 ms) | ± (10% +1 ms) | Same |
| mA | 2mA | 2mA | Same |
| kVp | 70kVp | 70kVp | Same |
| Waveform | Constant Potential (DC) | Constant Potential (DC) | Same |
| Total Filtration | 1.5mmAl | 1.5mmAl | Same |
| Half-Value Layer (HVL) | 1.6mm Al | 1.6mm Al | Same |
| X-ray Focal Spot | 0.4mm | 0.4mm | Same |
| Average Number of 0.5s Exposures with Fully Charged Battery | 500 | 500 | Same |

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| Device Characteristic | Subject Device Diagnostic X-Ray Equipment Model POCT22 (K252909) | Predicate Device Portable X-ray System Model Ray98(P) (K231449) | Comparison |
| --- | --- | --- | --- |
| Performance standards | IEC 60601-1 | IEC 60601-1 | Same |
| | IEC 60601-1-2 | IEC 60601-1-2 | |
| | IEC 60601-1-3 | IEC 60601-1-3 | |
| | IEC 60601-1-6 | IEC 60601-1-6 | |
| | IEC 60601-2-65 | IEC 60601-2-65 | |
| | IEC 62304 | IEC 62304 | |
| | IEC 62366 | IEC 62366 | |
| | ISO 14971 | ISO 14971 | |

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.
- Electrical test performed by KCTL, Inc. Laboratories, Inc., Korea.

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# 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 Diagnostic X-Ray Equipment Model POCT22 performs similar functions, in a similar environment as the predicate device. Diagnostic X-Ray Equipment Model POCT22 uses similar technology as the predicate device, based on well-known technology. Diagnostic X-Ray Equipment Model POCT22 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, Diagnostic X-Ray Equipment Model POCT22, is at least as safe and effective as the predicate device and warrants a finding of substantial equivalence to the legally marketed device.