(129 days)
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No
The description focuses on the hardware and basic X-ray generation process, with no mention of AI, ML, or advanced image processing that would typically indicate AI/ML use.
No.
The device is used to produce diagnostic x-ray images, which are used for diagnosis, not therapy.
Yes
The device is an x-ray system intended for producing "diagnostic x-ray images" for the purpose of diagnosing "tooth and jaw."
No
The device description clearly outlines hardware components such as an X-ray tubehead, controls, power source (battery pack), and a high frequency inverter, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This device is an X-ray system that generates images of the tooth and jaw within the patient's body.
- The intended use is for producing diagnostic X-ray images using intraoral image receptors. This is a form of medical imaging, not in vitro testing.
- The device description clearly outlines its function as an X-ray generator and imaging system. It describes the process of generating X-rays that penetrate the tooth and jaw to produce images on receptors.
The information provided describes a medical imaging device used for diagnosis based on the physical properties of the body, not on the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Portable X-ray System (Model: DXR-1) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Product codes (comma separated list FDA assigned to the subject device)
EHD, MUH
Device Description
DXR-1, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger.
The potable X-ray system, DXR-1, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of DXR-1 starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)
This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The DXR-1 produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
tooth and jaw
Indicated Patient Age Range
both adult and pediatric subjects.
Intended User / Care Setting
trained dentists and dental technicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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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K0&2 f75
Image /page/0/Picture/1 description: The image shows the word "EXARO" in a stylized font. A line crosses through the "X" in the word. The letters are bold and have a textured appearance.
FEB - 5 2009
Exhibit 5 510(k) Summary
Portable X-Ray System / Model: DXR-1
గా
Submitter and US Official Correspondent
| Submitter: | EXARO Co., Ltd. |
|---|---|
| Address: | #1201 World Meridian Venture Center I |
| 426-5 Gasan-Dong, Gumcheon-Gu | |
| Seoul, 153-803, Korea | |
| Official Correspondent: | Shin Kuk Yoo, BD Manager |
| Telephone No.: | 801-303-7440 (Ext. 202) |
| Fax No.: | 801-303-7455 |
| Email: | skyone@LSKBioPartners.com |
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Establishment Registration Number The firm will be registered and listed prior to 2. distribution of medical device.
Device Information Proprietary/Trade Name: Portable X-Ray System (Model: DXR - 1) Common/Usual Name: Portable X-Ray System Classification Name: Extraoral Source X-Ray System Product Code: EHD Device Class: Class II per regulation 21 CFR 872.1800 -
Equivalent Legally Marketed Device 4.
| Manufacturer: | GENORAY Co., Ltd. |
|---|---|
| Device Name: | Portable X-Ray System (Model: PORT-X II) |
| 510(k) Number: | K063121 (Decision Date - Jan. 11, 2007) |
| Classification: | Extraoral Source X-Ray System: EHD, Class II per |
| regulation 21 CFR 872.1800 |
Description of the Device ട്.
DXR-1, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, controls and power source
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are assembled into a single hand-held enclosure. The package includes a battery charger.
The potable X-ray system, DXR-1, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of DXR-1 starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)
This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The DXR-1 produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
Indications for use 6.
The portable X-ray system (Model: DXR - 1) is intended to be used by trained dentists and dental technicians as extraoral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Safety, EMC and Performance Data 7.
The compliance of DXR-1 will satisfy the applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements.
EMS test was performed by SGS Testing Korea Co., Ltd. for DXR-1 in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements.
8. Safety and Effectiveness, comparison to Predicate
The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices.
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Substantial Eguivalence Chart တံ
. . . . . .
| Company | GENORAY Co. Ltd. | EXARO Co., Ltd. | |
|---|---|---|---|
| Model | PORT-X II | DXR-1 | |
| 510(k) No | K063121 | Not assigned yet | |
| Energy | Rechargeable 22.2V, DC Lithium | Rechargeable 25.2V, DC | |
| Source | Polymer battery pack | Lithium Polymer Battery pack | |
| Expose Time | 0.01-2.0 seconds, 0.01 increments | 0.01-1.6 seconds, 0.01 increments | |
| Time Accuracy | ±(10%+1ms) | ±(10%+1ms) | |
| Heat Capacity | 8.5 KHU | 8.5 KHU | |
| Power Output | 100 W | 180 W | |
| mA | 2mA fixed | 2mA fixed | |
| kVp | 60kV fixed | 60kV fixed | |
| Focal Spot | 0.8 mm | 0.8 mm | |
| Wave Form | Constant Potential (DC) | Constant Potential (DC) | |
| Safety, EMC and | |||
| performance | IEC 60601-1, IEC 60601-1-2, IEC | ||
| 60601-2-7, IEC 60601-2-28, IEC | |||
| 60601-2-32 | IEC 60601-1, IEC 60601-1-2, IEC | ||
| 60601-2-7, IEC 60601-2-28, IEC | |||
| 60601-2-32 | |||
| Source to skin | |||
| distance | 20cm | 20cm | |
| Cone Diameter | 7cm | 6 cm | |
| User Interface | Exposure time: up, down. | ||
| Selection buttons of parts of teeth, | |||
| adult and child, film and sensor | |||
| with display. | Exposure time: up, down. | ||
| Selection buttons of parts of teeth, | |||
| adult and child, film and sensor | |||
| with display. | |||
| Exposure switch | Control panel and remote controller | Control panel and remote | |
| controller | |||
| Tubehead | |||
| Mounting | Yes | Yes | |
| Intended Use | Intended to use by trained dentists and dental technicians as an extra- | ||
| oral x-ray source for producing diagnostic x-ray images using intra-oral | |||
| image receptors or film. It is intended to use for both adult and pediatric | |||
| subjects. |
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10. · Conclusion
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In reference to the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807 and the comparison information provided substantial equivalent chart above, the EXARO Co., Ltd., believes that the portable X-ray system (Model: DXR-1) is safe and effective and substantially equivalent to the predicate device (Model: PORT-X II).
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2009
EXARO Co., Ltd. % Mr. Shin Kuk Yoo LSK BioPartners, Inc. 215 South State Street, Suite 100B SALT LAKE CITY UT 84111
Re: K082875
Trade/Device Name: Portable X-Ray System (Model: DXR-1) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD and MUH Dated: January 29, 2009
Received: February 2, 2009
Dear Mr. Yoo:
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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Exhibit 4 Indications for Use
lications for use
510(k) number (if known): _KO82 875
Device Name: Portable X-Ray System (Model: DXR-1) Indications for Use:
The Portable X-ray System (Model: DXR-1) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Lewin
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 0810875 510(k) Number
15/336