(59 days)
Not Found
No
The summary describes a standard portable dental X-ray system and does not mention any AI or ML capabilities for image processing, diagnosis, or other functions. The performance studies focus on non-clinical testing against standards, and there is no mention of training or test sets typically associated with AI/ML development.
No
The device is used to capture radiographic images for dental diagnosis, which is a diagnostic purpose, not therapeutic.
Yes
The device is described as "a portable dental X-ray system that captures radiographic images for dental diagnosis" and is "designed to diagnose teeth and jaw through X-ray irradiation".
No
The device description clearly states it is a "handheld X-ray system" composed of hardware components like an X-ray generator, X-ray tube, power controller, etc. While it is controlled by software (firmware), it is fundamentally a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- DT-703 Function: The DT-703 is a dental X-ray system. It generates X-rays that pass through the patient's body (specifically the teeth, jaws, and oral structures) to create an image. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it "captures radiographic images for dental diagnosis using intraoral imaging sensors." This is an imaging modality, not an in vitro diagnostic test.
The description and intended use clearly place the DT-703 within the category of medical imaging devices, specifically for dental radiography.
N/A
Intended Use / Indications for Use
The DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
Product codes
EHD
Device Description
DT-703 is a handheld X-ray system powered by a rechargeable Li-ion polymer battery pack. DT-703 is an extra source X-ray generating device that is mainly designed for dental examination (on teeth, etc.). DT-703 is composed of X-ray generator with X-ray tube including device controller, power controller, user interface, beam limiting part, backscatter shielding glass, and optional remote exposure switch. DT-703 is designed to diagnose teeth and jaw through X-ray irradiation using an intra-oral image receptor. DT-703 is controlled by software (firmware) and the software level of concern is Moderate. The x-ray image detector (an integral part of a complete dental diagnostic system) is not part of the DT-703 X-ray device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaws, and/or other oral structures
Indicated Patient Age Range
adults and children
Intended User / Care Setting
trained and qualified dental practitioner or radiologist
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 Test Data:
Testing was performed in accordance with the following international standards:
IEC 60601-1:2005, AMD 1: 2012
IEC 60601-2-65 Edition 1.0 2012-09 Medical Electrical Equipment - Part 2-65: Particular Requirements for the Basic Safety And Essential Performance of Dental Intra-Oral X-Ray Equipment
IEC 60601-1-2 Edition 4.1 2014-02 Medical Electrical Equipment – Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
IEC 60601-1-3 Edition 2.1 2013-04 Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety And Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
ISO 14971 Third Edition 3 2019 Medical Devices – Application Of Risk ManagementTo Medical Devices
IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From them, For Use In Portable Applications [Including: Corrigendum 1 (2013)]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KaVo NOMAD Pro 2 Handheld X-ray System (K173319)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
June 27, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ECOTRON Co., Ltd % Mr. Dave Kim Regulatory Affairs Mtech Group 7505 Fannin St, Suite 610 HOUSTON TX 77054
Re: K221233
Trade/Device Name: DT-703 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: April 20, 2022 Received: April 29, 2022
Dear Mr. Kim:
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, 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
2
Indications for Use
510(k) Number (if known) K221233
Device Name DT-703
Indications for Use (Describe)
The DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
Type of Use (Select one or both, as applicable)
| ü 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 the logo for eco & electronics eddTRON. The logo is composed of a blue square with the letters "edd" in white, followed by the text "eco & electronics" in black. Below this is the word "TRON" in gray. The logo is simple and modern, and it is likely used to represent a company that specializes in electronics.
510(k) Summary K221233
This summary of 510(k) is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.
Date 510(k)submitted: 4/25/2022
| 1. | Submitter Information: | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sumitter's Name:ECOTRON Co., LtdAddress:404, 504, 505Ho, Hanshin IT Tower II, 47,Digital-ro 9-gil, Geumcheon-Gu,Seoul, Republic of Korea 08511Contact Person:Sang Bong Lee, R&D ManagerTelephone Number:(02)-2025-3760Email:lsb@ecotron.co.krOfficial Correspondent:Dave Kim, MBAMtech GroupAddress:7505 Fannin St. Suite 610, Houston, TX 77054Tel:713-467-2607Email:davekim@mtech-inc.net | Sumitter's Name: | ECOTRON Co., Ltd | Address: | 404, 504, 505Ho, Hanshin IT Tower II, 47, | Digital-ro 9-gil, Geumcheon-Gu, | Seoul, Republic of Korea 08511 | Contact Person: | Sang Bong Lee, R&D Manager | Telephone Number: | (02)-2025-3760 | Email: | lsb@ecotron.co.kr | Official Correspondent: | Dave Kim, MBA | Mtech Group | Address: | 7505 Fannin St. Suite 610, Houston, TX 77054 | Tel: | 713-467-2607 | Email: | davekim@mtech-inc.net | ||||
| Sumitter's Name: | ECOTRON Co., Ltd | ||||||||||||||||||||||||
| Address: | 404, 504, 505Ho, Hanshin IT Tower II, 47, | ||||||||||||||||||||||||
| Digital-ro 9-gil, Geumcheon-Gu, | |||||||||||||||||||||||||
| Seoul, Republic of Korea 08511 | |||||||||||||||||||||||||
| Contact Person: | Sang Bong Lee, R&D Manager | ||||||||||||||||||||||||
| Telephone Number: | (02)-2025-3760 | ||||||||||||||||||||||||
| Email: | lsb@ecotron.co.kr | ||||||||||||||||||||||||
| Official Correspondent: | Dave Kim, MBA | ||||||||||||||||||||||||
| Mtech Group | |||||||||||||||||||||||||
| Address: | 7505 Fannin St. Suite 610, Houston, TX 77054 | ||||||||||||||||||||||||
| Tel: | 713-467-2607 | ||||||||||||||||||||||||
| Email: | davekim@mtech-inc.net | ||||||||||||||||||||||||
| 2. | Device Name: |
| Device Name: |
|---|
| Proprietary Name: |
| Manufacturer Name: | |
|---|---|
| Common Name: | |
| Classification Name: | |
| CFR Number: | |
| Device Class: | |
| Product Code: |
DT-703 ECOTRON Handheld X-ray System Extraoral Source X-ray System 872.1800 II EHD
3. Predicate Device:
Proprietary Name: Manufacturer Name: Common Name: Classification Name: CFR Number: Device Class: Product Code:
KaVo NOMAD Pro 2 Handheld X-ray System (K173319) Aribex Handheld X-ray System Extraoral Source X-ray System 872.1800 II EHD
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Image /page/4/Picture/0 description: The image shows the logo for "eco & electronics edotron". The logo has a blue square design on the left side, followed by the text "eco & electronics" in black font. Below this text is the word "edoTRON" in a larger, gray font. The logo appears to be for an electronics company with an eco-friendly focus.
4. Description of Device:
DT-703 is a handheld X-ray system powered by a rechargeable Li-ion polymer battery pack. DT-703 is an extra source X-ray generating device that is mainly designed for dental examination (on teeth, etc.). DT-703 is composed of X-ray generator with X-ray tube including device controller, power controller, user interface, beam limiting part, backscatter shielding glass, and optional remote exposure switch. DT-703 is designed to diagnose teeth and jaw through X-ray irradiation using an intra-oral image receptor. DT-703 is controlled by software (firmware) and the software level of concern is Moderate. The x-ray image detector (an integral part of a complete dental diagnostic system) is not part of the DT-703 X-ray device.
Optional parts available:
- Remote Exposure Switch
- . Backscatter Shield
- . Rectangular Cover (FOV 2x3)
- . Rectangular Cover (FOV 3x4)
5. Indications for Use:
DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
6. Description of Substantial Equivalence: Technological Characteristics:
DT-703 has similar design components andoperating features as the predicate device, KaVo NOMAD Pro 2 Handheld X-ray System (K173319).
The handheld device features a main unit (tube head), rechargeable battery (handset) and charger. The main components of the tube head including X-ray tube (70 kV, 3 mA), internal shielding and external backscatter shielding are similar to the predicate device. The functionality of the user interface is also similar to the predicate device.
The power is supplied by a rechargeable Lithium Ion battery core pack built into a handset. The design for DT-703 is equipped with a 22.2 VDC, 1.0 Ahr battery core pack compared to the predicate device (KaVo NOMAD Pro 2 Handheld X-ray System - K173319) design of 21.6 VDC, 1.7 Ahr. The DT-703 battery core pack is compliant with IEC 62133-2.
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Image /page/5/Picture/0 description: The image shows the logo for "eco & electronics eddotron". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in black and is above the word "eddotron", which is in gray.
Testing has been completed on basic safety and essential performance and the device complies with IEC 60601-1; IEC 60601-1-2 (Ed. 4.1); IEC 60601-1-3, and IEC 60601-2-65.
| | DT-703 Handheld
Dental X-ray System
(Subject Device) | KaVo NOMAD Pro2
Handheld X-ray System
(K173319) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS
FOR USE: | DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children. | The KaVo NOMAD Pro 2 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors. |
| MECHANICAL: | | |
| Size: Body (mm/inch) | 259 x 277 x 165 mm
(10"L x 11"H x 6.5"W) | 11"L x 10.5"H x 5.5"W |
| Weight | 1.5 kg (3.3 lbs) | 6.0 lbs. |
| Source to skin distance | 20 cm | 21 cm |
| Cone diameter | 6 cm | 6 cm |
| User Interface | Same, plus several user-selectable preset times. | |
| Backscatter radiation protection | 165mm (6.5") dia. Pb-filled acrylic plastic, backscatter shield | 6.75" dia. Pb-filled acrylic plastic scatter shield |
| Exposure switch | Trigger located on handset / optional remote switch | Trigger located on handset |
| Tubehead mounting | Handheld | Handheld |
| ELECTRICAL: | | |
| Tubehead | CEI OX/70-3 | Cyprus PSOC CY8C29866 |
| Energy Source | Rechargeable 22.2 V Li-ion polymer battery pack | Rechargeable 21.6 V DC Li-ion battery core pack |
| Capacity | 1.0 A-hr | 1.7 A-hr |
| Exposure Time | 0.02 – 0.5 seconds in 0.01 increments | 0.02 – 1.0 seconds in 0.01 increments |
| mA | 3 mA fixed | 2.5 mA fixed |
| kVp | 70 kVp fixed | 60 kVp fixed |
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| Image: edotron logo | ||
|---|---|---|
| Electrical Safety | ||
| Standards | IEC 60601-1:2005, AMD1:2012 | AAMI ES60601-1:2005/(R)2012 And |
| A1:2012 | ||
| EMI Standards | IEC60601-1-2: Ed. 4.1 | IEC60601-1-2 Ed. 4 |
| X-RAY | ||
| PERFORMANCE: |
Similar technological characteristics for the proposed device DT-703 and the predicate device KaVo Nomad Pro2 seem to indicate substantial equivalence.
Non-Clinical Test Data:
Testing was performed in accordance with the following international standards:
IEC 60601-1:2005, AMD 1: 2012
IEC 60601-2-65 Edition 1.0 2012-09 Medical Electrical Equipment - Part 2-65: Particular Requirements for the Basic Safety And Essential Performance of Dental Intra-Oral X-Ray Equipment
IEC 60601-1-2 Edition 4.1 2014-02 Medical Electrical Equipment – Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
IEC 60601-1-3 Edition 2.1 2013-04 Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety And Essential Performance – Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
ISO 14971 Third Edition 3 2019 Medical Devices – Application Of Risk ManagementTo Medical Devices
IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From them, For Use In Portable Applications [Including: Corrigendum 1 (2013)]
7
Image /page/7/Picture/0 description: The image is a logo for "eco & electronics edotron". The logo has a blue icon on the left, followed by the text "eco & electronics" in a smaller font. Below the text is the word "edoTRON" in a larger, gray font. The logo is simple and modern, with a focus on the company's name and its association with eco-friendly electronics.
FDA Guidance Documents Utilized:
Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use, issued December 24, 2008
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued May 11, 2005
Pediatric Information for X-ray Imaging Device Premarket Notifications, issued May 10, 2012
Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, technological characteristics, principleof operation, features and performance data, the sponsor believes that the subject device, DT-703 is deemed to be substantially equivalent to the predicate device, KaVo NOMAD Pro 2.