(81 days)
Not Found
No
The description focuses on the hardware and basic X-ray generation process, with no mention of AI/ML for image processing, diagnosis, or any other function.
No.
The device is described as an X-ray system used for producing diagnostic images of teeth and jaws, which is a diagnostic purpose, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for producing diagnostic x-ray images." Also, the "Device Description" mentions that the device "is designed to diagnose tooth and jaw through generated and controlled X-ray."
No
The device description clearly outlines hardware components such as an X-ray tube head, 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 Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The provided description clearly states that this device is a portable X-ray system used to produce diagnostic X-ray images of the tooth and jaw. This process involves generating radiation that passes through the body (in vivo) to create an image on a receptor.
The device's function is based on imaging the internal structure of the body using radiation, not on analyzing samples taken from the body. Therefore, it falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Product codes
EHD
Device Description
EXARO, Xray2GO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, Xray2GO, 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 operating principle of EXARO, Xray2GO 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 tube head, electrical protective devices, and other elements. The EXARO, Xray2GO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
tooth and jaw area
Indicated Patient Age Range
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
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 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.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2014
Osstem Implant Co. Ltd. % Patrick Lim OA/RA Manager, Hiossen Inc. 85 Ben Fairless Drive FAIRLESS HILLS, PA 19030
Re: K141497
Trade/Device Name: Portable X-Ray System (Model: EXARO, Xray2GO) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: II Product Code: EHD Dated: July 25, 2014 Received: July 28, 2014
Dear Mr. Lim:
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.f)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K141497/S001
Device Name: Portable X-ray System (Model: EXARO, Xray2GO)
Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k): K141497/S001
Page 1 of __
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OSSTEM Implant Co., Ltd.
301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com
510K Summary
Portable X-Ray System / Model : EXARO, Xray2GO
| 1. | Company and Correspondent Making the Submission | ||
|---|---|---|---|
| Submitter : | OSSTEM Implant Co,.Ltd. | ||
| Address : | 301ho, Korea Electronics Cooperation B/D 114 | ||
| Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea | |||
| 153-803 | |||
| Tel : | 82-70-4394-5029 | ||
| Fax : | 82-2-863-3479 | ||
| E-mail : | qa@osstem.com | ||
| Contact : | Mr. Mooyong Park |
-
- US Agent for FDA Contact : Name : HIOSSEN Inc., Address : 85 Ben Fairless Dr. Fairless Hills, PA 19030 USA Contact : Patrick Lim, QA/RA manager. Telephone No.: 888-678-0001 Fax No.: 267-759-7004 Email: dtlim@osstem.com
-
- Device Information Proprietary/Trade Name: Common/Usual Name: Classification Name: Product Code: Device Class:
Portable X-Ray System (Model: EXARO, Xray2GO) Portable X-Ray System Extraoral Source X-Ray System EHD Class II per regulation 21 CFR 872.1800
-
- Equivalent Legally Marketed Device K number: K122124 Proprietary/Trade Name: Portable X-Ray System(Model:EXARO) Common/Usual Name: Portable X-Ray System Classification Name: Extraoral Source X-Ray System Product Code: EHD Class II per regulation 21 CFR 872.1800 Device Class:
- న. Date Prepared: 6/4/2014
4
OSSTEM Implant Co., Ltd.
301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com
6. Description of the Device
EXARO, Xray2GO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, Xray2GO, 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 operating principle of EXARO, Xray2GO 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 tube head, electrical protective devices, and other elements. The EXARO, Xray2GO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
| Characteristic | Proposed
OSSTEM Implant Co,. Ltd.
EXARO, Xray2GO | Predicate
OSSTEM Implant Co., Ltd.
EXARO | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| 510(k) number | Not assigned yet | K122124 | |
| Anode current | 3mA | 2mA | |
| Expose time | 0.011.6 seconds, 0.01 increments | 0.012.0 seconds, 0.01 increments | |
| Battery | Battery part No. | SPB605060H4 | JBL7451251700100FJ |
| | Battery Current | Current : 12.0CmA | Current : 1.0CmA |
| | Battery Max. Current | Max. current : 1900mAh | Max. current : 950mAh |
| Battery case size | 87 x 111.9 x 42H (mm) | 87 x 111.9 x 36H (mm) | |
| | NEW | Predicate Device | |
| Manufacturer | OSSTEM IMPLANT Co., Ltd. | OSSTEM IMPLANT Co., Ltd. | |
| Model | EXARO, Xray2GO | EXARO | |
| 510(k)
Number | Not assigned yet | K122124 | |
| Energy
Source | Rechargeable 25.2V, DC Lithium
Polymer Battery pack | Rechargeable 25.2V, DC Lithium
Polymer Battery pack | |
| Expose Time | 0.011.6 seconds, 0.01 increments | 0.012.0 seconds, 0.01 increments | |
| Time Accuracy | ±(10%+1ms) | ±(10%+1ms) | |
| Heat Capacity | 8.5 KHU | 8.5 KHU | |
| Power Output | 100W | 100W | |
| mA | 3mA Fixed | 2mA Fixed | |
| kVp | 60kV Fixed | 60kV Fixed | |
| Focal Spot | 0.8mm | 0.8mm | |
| 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 | 6cm | 6cm | |
| 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 | |
| Principle of
Operation | X-ray generated by high voltage
electricity into X-ray tube, which
penetrates hand, tooth and jaw, and
makes X-ray images on receptor
(Chemical Film or Digital Sensor) | X-ray generated by high voltage
electricity into X-ray tube, which
penetrates hand, tooth and jaw, and
makes X-ray images on receptor
(Chemical Film or Digital Sensor) | |
| Intended Use intended to be used by trained dentists and dental technicians as extra-oral x-
ray source for producing diagnostic x-ray images using intra-oral image
receptors or film. Its use is intended for both adult and pediatric subjects. | | | |
A list of modifications made to the subject device is below:
-
- Indications for use (Intended Use) The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
-
- Safety, EMC and Performance Data No additional testing was added for this submission based on the modifications.
-
- 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.
5
TEM®
OSSTEM Implant Co., Ltd.
301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com
10. Substantial Equivalence Chart
6
OSSTEM Implant Co., Ltd.
301ho, Korea Electronics Cooperation B/D 114 Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea, #153-803 Tel: +82 70-4394-5029 Fax: +82 51 850-4341 www.osstem.com
The subject and predicate devices are similar in indications, design, technology, functions, and principle of operation.
The differences between two devices are anode current, expose time, battery (part no., current, and maximum current) and battery case size.
Any differences do not raise different questions of safety and effectiveness than the predicate. Therefore, there is no difference between the subject and predicate with respect to the indications or technology.
-
- Conclusion
In reference to the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807 and the comparison information provided substantial equivalent chart above, the OSSTEM IMPLANT Co., Ltd., believes that the portable X-ray system (Model: EXARO, Xray2GO) is substantially equivalent to its predicate device.
- Conclusion