(56 days)
Not Found
No
The summary describes a portable X-ray device with a timer and does not mention any AI/ML capabilities or image processing features.
No
The device is described as a diagnostic X-ray system used to produce diagnostic x-ray images and assist in the diagnosis of diseases of the teeth, jaw, and oral structure. It does not provide any therapeutic function.
Yes
The device is described as a "diagnostic X-ray system" used for "producing diagnostic x-ray images" and for "diagnosis of diseases of the teeth, jaw, and oral structure".
No
The device description explicitly states it is a "portable x-ray device" with an "x-ray source, a tube, is located inside the portable device," indicating it is a hardware device that emits ionizing radiation. While it includes software validation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that this device is an X-ray system used to produce images of the teeth, jaw, and oral structure within the patient's body. It does not analyze biological samples like blood, urine, or tissue.
- The device is an imaging system. Its primary function is to generate images using X-rays for diagnostic purposes, which falls under the category of medical imaging devices, not IVDs.
The description focuses on the device's function as an X-ray source and its use in generating images for diagnosis, which is characteristic of a medical imaging device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EHD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Teeth, jaw, and oral structure
Indicated Patient Age Range
Adults and pediatric subjects.
Intended User / Care Setting
Trained dentists and dental technicians. Used in general dentistry, for special need patients, nursing home patients, and other special situations.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- 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. Conformity with all standards was determined by the device manufacturer, Ningbo Runyes Ltd., Korea. Electrical test performed by KCTL, Inc. Laboratories, Inc., Korea.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
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.(b)
Classification. Class II.
0
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
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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510k FDA Consulting
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 (xz02@runyes.com) Contact:
Date Prepared: July 13, 2023
Preparer/Consultant
510K FDA Inc. 156 East Granada Blvd. Ormond Beach, FL 32176
Phone: 386-506-8711
Fax: (386) 675-4621 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 |
4
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.
5
Comparison of Technological Characteristics with Predicate
The following table compares technological and other characteristics of the subject and predicate device.
| Device
Characteristic | Subject Device
Portable X-ray System
Model Ray98(P) | Predicate Device Mobile-X
Portable X-ray System
(K180561) | Comparison |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510(k) Owner | Ningbo Runyes Medical
Instrument Co., Ltd. (China) | Denterprise International,
Inc.
(USA) | NA |
| Classification &
Product Code | 872.1800; EHD | 872.1800; EHD | Similar |
| 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. | Similar |
| Indication 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. | 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 | 5.75" x 6.0" x 9.5" | 6.5" x 6.0" x 10.5" | Difference of
design, size |
| Source to Skin
Distance | $20.5 cm ±0.5cm$ | $20.5 cm$ | Difference .5
cm |
| Cone diameter | $6.0 cm ±0.5cm$ | $6.0 cm$ | Difference
±0.5cm |
| Device
Characteristic | Subject Device
Portable X-ray System
Model Ray98(P) | Predicate Device Mobile-X
Portable X-ray System
(K180561) | 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,
image-receptor type, and
tooth selection icons on an
LCD display. | Difference;
subject device
does not set
image-receptor
type |
| 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. | Similar |
| 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 | 0.01 ~ 1.3 seconds in 0.01
or 0.05 increments | Difference;
subject device
has higher
exposure time
limits and fixed
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
(HVL) | 1.6mm Al | 1.5mm Al | Difference;
subject device
has higher
HVL |
| X-ray Focal Spot | 0.4mm | 0.4mm | Similar |
| Device
Characteristic | Subject Device
Portable X-ray System
Model Ray98(P) | Predicate Device Mobile-X
Portable X-ray System
(K180561) | Comparison |
| Average Number of
0.5s Exposures with
Fully Charged
Battery | 500 | 400 | Difference;
subject device
has higher
average
exposures |
| Performance
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 | 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 | Similar |
6
7
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.
8
- 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.