PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)

{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 __ {3}------------------------------------------------ ## 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<br>Gasandigital2ro, Geumcheon-gu, Seoul-si, Korea<br>153-803 | | | | Tel : | 82-70-4394-5029 | | | | Fax : | 82-2-863-3479 | | | | E-mail : | qa@osstem.com | | | | Contact : | Mr. Mooyong Park | | - 2. 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 - 3. 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 - 4. 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<br>OSSTEM Implant Co,. Ltd.<br>EXARO, Xray2GO | Predicate<br>OSSTEM Implant Co., Ltd.<br>EXARO | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | 510(k) number | Not assigned yet | K122124 | | | Anode current | 3mA | 2mA | | | Expose time | 0.01~1.6 seconds, 0.01 increments | 0.01~2.0 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)<br>Number | Not assigned yet | K122124 | | | Energy<br>Source | Rechargeable 25.2V, DC Lithium<br>Polymer Battery pack | Rechargeable 25.2V, DC Lithium<br>Polymer Battery pack | | | Expose Time | 0.01~1.6 seconds, 0.01 increments | 0.01~2.0 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<br>Performance | IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-7, IEC 60601-2-28, IEC<br>60601-2-32 | IEC 60601-1, IEC 60601-1-2, IEC<br>60601-2-7, IEC 60601-2-28, IEC<br>60601-2-32 | | | Source to skin<br>Distance | 20cm | 20cm | | | Cone Diameter | 6cm | 6cm | | | User Interface | Exposure time: up, down.<br>Selection buttons of parts of teeth,<br>adult and child, film and sensor with<br>display. | Exposure time: up, down.<br>Selection buttons of parts of teeth,<br>adult and child, film and sensor with<br>display. | | | Exposure switch | Control panel and remote controller | Control panel and remote controller | | | Tubehead<br>Mounting | Yes | Yes | | | Principle of<br>Operation | X-ray generated by high voltage<br>electricity into X-ray tube, which<br>penetrates hand, tooth and jaw, and<br>makes X-ray images on receptor<br>(Chemical Film or Digital Sensor) | X-ray generated by high voltage<br>electricity into X-ray tube, which<br>penetrates hand, tooth and jaw, and<br>makes X-ray images on receptor<br>(Chemical Film or Digital Sensor) | | | Intended Use intended to be used by trained dentists and dental technicians as extra-oral x-<br>ray source for producing diagnostic x-ray images using intra-oral image<br>receptors or film. Its use is intended for both adult and pediatric subjects. | | | | A list of modifications made to the subject device is below: - 7. 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. - 8. Safety, EMC and Performance Data No additional testing was added for this submission based on the modifications. - 9. 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. - 11. 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.