(30 days)
Not Found
No
The summary describes a standard portable dental X-ray system with basic software for controlling hardware operation. There is no mention of image processing, AI, ML, or any related concepts. The performance studies focus on electrical safety, software validation (for basic control), and radiation leakage, not algorithmic performance.
No
The device is described as a "diagnostic X-ray system" used for "producing diagnostic x-ray images" and "diagnosis of diseases." It does not mention any therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The MobileX Portable X-ray System is a diagnostic X-ray system..." and also mentions its use for "producing diagnostic x-ray images" and "diagnosis of diseases of the teeth, jaw, and oral structure."
No
The device description explicitly states it is a "handheld xray device" with an "x-ray source, a tube, is located inside the handheld device." While it includes software, it is clearly a hardware device that utilizes software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The MobileX Portable X-ray System is an X-ray imaging device. It uses ionizing radiation to create images of the teeth, jaw, and oral structure within the patient's body.
- Intended Use: The intended use clearly states it's for producing diagnostic x-ray images using intra-oral receptors. This is a form of medical imaging, not in vitro testing.
The device description and intended use clearly indicate that this is an imaging device used directly on the patient, not a device that analyzes samples taken from the patient.
N/A
Intended Use / Indications for Use
The MobileX Portable X-ray System 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
MobileX Portable X-ray System of Denterprise International, Inc., is a handheld xray 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 handheld 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 software is designed for a button operated device to be used by a user and a display window to be observed by the user. The software is for controlling the operation of the hardware according to the user operation that is required for this device. This software is new but this type of software is common for use in the handheld x-ray systems.
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
both adults and pediatric subjects.
Intended User / Care Setting
trained dentists and dental technicians
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)
The following performance was completed on the subject device in support of the substantial equivalence determination of the predicate device. Clinical data was not needed to support substantial equivalence.
- Electrical Safety and EMC
- Software Validation
- Biocompatibility
- Usability
- Clinical Comparison
- Risk Assessment /Radiation Leakage
All tests were performed in accordance with ISO standards and tests are recognized by FDA.
None of the standards were adapted for application to the device under review.
There were no requirements of any standard that were not applicable to the device.
No deviations from the standards were applied.
No differences exist between the tested device and the device to be marketed.
Test of leakage radiation according to EN 60601-1-3:2010, sub-clause 12.2, 12.4 and IEC 60601-2-65. sub-clause 203.12.2. 203.12.3. 203.12.4. Also tested leakage radiation according to EN 60601-1-3:2010, sub-clause 13.4. The device passed and test methods were verified according to these ISO standards.
Conformity with all standards was determined by the device manufacturer, Remedi Co., 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Denterprise International, Inc. % Ms. Joyce St. Germain Regulatory Dept. Manager 510k FDA Consulting / Denterprise International, Inc. 100 E. Granada Blvd., Suite 219 ORMOND BEACH FL 32176
April 4, 2018
Re: K180561
Trade/Device Name: MobileX Portable X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: February 28, 2018 Received: March 5, 2018
Dear Ms. Germain:
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. 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180561
Device Name MobileX Portable X-ray System
Indications for Use (Describe)
The MobileX Portable X-ray System 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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Image /page/3/Picture/0 description: The image shows a stylized black and white drawing of a bird of prey, possibly an eagle or falcon. The bird is depicted in profile, facing right, with a large, stylized wing extending upwards and to the left. The wing is composed of several distinct feathers, each with a curved shape. The bird's head is relatively small and features a sharp, curved beak, suggesting its predatory nature.
510k FDA Consulting
Medical Device Clearances
100 East Granada Blvd., Suite 219
Ormond Beach, FL 32176
386-506-8711
510(k) Summary
Submitter/Applicant
Denterprise International, Inc. 100 E. Granada Blvd., suite 219 Ormond Beach, FL 32176, USA
877-509-3180 Phone: Fax: 855-235-7902 Contact: Claude Berthoin, CEO (claude@denterpriseintl.com) Date Prepared: February 28, 2018
Preparer/Consultant
510k FDA Consulting / Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
Phone: 386-506-8711 855-235-7902 Fax:
Primary Contact: Joyce St. Germain, Regulatory Dept. Mgr., joyce@510kfda.com Secondary Contacts: Claude Berthoin, CEO (claude@denterpriseintl.com).
Device Classification
| Trade/Model Names: | MobileX Portable X-ray System / (T-100 |
|---|---|
| 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 |
4
Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K152859 |
|---|---|
| Applicant: | Digimed Co., Ltd., Korea |
| Date Cleared: | December 3, 2015 |
| Trade Name: | Portable X-ray System (Model: MiniX-V) |
| 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
MobileX 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 sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
Device Description
MobileX Portable X-ray System of Denterprise International, Inc., is a handheld xray 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 handheld 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 software is designed for a button operated device to be used by a user and a display window to be observed by the user. The software is for controlling the operation of the hardware according to the user operation that is required for this device. This software is new but this type of software is common for use in the handheld x-ray systems.
5
Comparison of Technological Characteristics with Predicate
The following table compares technological and other characteristics of the subject and predicate device.
Note: This device has software with a Moderate Level of Concern.
Table 5.1 -- Technological Comparison Subject Model: T-100
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | Mobile-X Portable | ||
| X-ray System | Portable X-ray | ||
| System: Model | |||
| MiniX-V | NA | ||
| 510(k) Owner | Denterprise | ||
| International, Inc. | |||
| (USA) | Digimed Co., Ltd. | ||
| (Korea) | 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 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 | 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 | Same | ||
| both adults and | |||
| pediatric subjects. | both adults and | ||
| pediatric subjects. | |||
| Size | 6.5" x 6.0" x 10.5" | 4.8" x 8.7" x 5.3" | Difference of |
| design shape/size | |||
| Source to Skin | 20.5 cm | 20 cm | Difference/ |
| Subject Device | |||
| .5cm farther | |||
| from patient | |||
| Cone diameter | 6.0cm | 5.5 cm | Difference .5cm |
| User interface | Up-down buttons | ||
| for exposure time | |||
| selection with | |||
| timer display. | |||
| Additionally, | |||
| several user- | |||
| selectable present | |||
| times with patient | |||
| size, image- | |||
| receptor type, and | |||
| tooth selection | |||
| icons on an LCD | |||
| display. | Up-down buttons | ||
| for exposure time | |||
| selection with timer | |||
| display. | |||
| Additionally, | |||
| several user- | |||
| selectable present | |||
| times with patient | |||
| size, image-receptor | |||
| type, and tooth | |||
| selection icons on | |||
| an LCD display | Same | ||
| Backscatter radiation | |||
| protection | 153mm (6.02") dia. | ||
| 12mm thick pb- | |||
| filled acrylic | |||
| plastic scatter | |||
| shield | 6.3" dia. 12mm | ||
| thick pb-filled | |||
| acrylic plastic | |||
| scatter shield | Slight mm | ||
| Difference | |||
| Exposure switch | Exposure button at | ||
| front cover on right | |||
| hand side. | Exposure button at | ||
| front cover on right | |||
| hand side. | Same | ||
| Tube-head mounting | Handheld, on | ||
| optional arms or on | |||
| a tripod | Handheld, on | ||
| optional arms or on | |||
| a tripod | Same | ||
| Electrical | |||
| Information | |||
| Energy source | Rechargeable | ||
| 11.1V DC Lithium | |||
| Polymer battery | Rechargeable 22.2 | ||
| V DC Lithium | |||
| Polymer battery | Same | ||
| Exposure time | 0.01 ~ 1.3 seconds | ||
| in 0.01 or 0.05 | |||
| increments | 0.01 ~ 2.0 seconds | ||
| in 0.01 increments | Difference | ||
| Time accuracy | ±(10% +1 ms) | ±(10% +1 ms) | Same |
| mA | 2mA fixed | 2mA fixed | Same |
| kVp | 70kVp fixed | 70kVp fixed | Same |
| Waveform | Constant Potential | ||
| (DC) | Constant Potential | ||
| (DC) | Same | ||
| Duty Cycle | 1:60 | 1:60 | Same |
| 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 | |||
| IEC 6100-3-2 | |||
| IEC 6100-3-3 | |||
| ISO 14971 | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| CISPR 11 | |||
| IEC61000-3-2 | |||
| IEC61000-3-3 | |||
| IEC 60601-1-3 | |||
| IEC 60601-2-65 | Different/Subject | ||
| Device has | |||
| additional test |
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pack
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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 exposure time is slightly less with the subject device matched to the predicate. The differences of the device are minor and do not raise new issues of safety and effectiveness.
Non-Clinical Performance Data
The following performance was completed on the subject device in support of the substantial equivalence determination of the predicate device. Clinical data was not needed to support substantial equivalence.
- Electrical Safety and EMC ●
- Software Validation ●
- Biocompatibility .
- Usability ●
- Clinical Comparison
- Risk Assessment /Radiation Leakage ●
8
- . All tests were performed in accordance with ISO standards and tests are recognized by FDA.
- None of the standards were adapted for application to the device under . review.
- There were no requirements of any standard that were not applicable to the device.
- No deviations from the standards were applied. ●
- No differences exist between the tested device and the device to be marketed.
- Test of leakage radiation according to EN 60601-1-3:2010, sub-clause 12.2, 12.4 and IEC 60601-2-65. sub-clause 203.12.2. 203.12.3. 203.12.4. Also tested leakage radiation according to EN 60601-1-3:2010, sub-clause 13.4. The device passed and test methods were verified according to these ISO standards.
- Conformity with all standards was determined by the device manufacturer, ● Remedi Co., Ltd., Korea.
- . Electrical test performed by KCTL, Inc. Laboratories, Inc., Korea.
Specific Guidance Document
There are two FDA Specific Guidance Documents associated with the device: Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use. This submission utilized this guidance to develop this device to ensure the safety of this device for both the operators and the patients. The Guidance document: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices also 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,
9
21 CFR 1020.31: Radiographic Equipment
Substantial Equivalence
The above comparison chart shows the subject and predicate devices are substantially equivalent in technological characteristics.
Both devices have:
- The same function and used in the same environment.
- The same indications for use and the same intended use. ●
- . The same manufacturing process and technological characteristics.
- . Both devices have completed the ISO standardized testing and have passed and the tests are in the comparison chart shown above.
Conclusion
The subject and predicate device have the same indications for use, the same intended use and have similar technological characteristics. The MobileX Portable X-ray System performs the same identical functions, in the same environment as the predicate device. MobileX uses the same technology as the predicate device, based on well-known technology. MobileX 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, MobileX Portable X-ray System, is at least as safe and effective as the predicate device and warrants a finding of substantial equivalence to the legally marketed device.