PORTABLE X-RAY SYSTEM, MODEL HAND-RAY

K092772 · Hanjin Digi-X Co., Ltd. · EHD · Jan 6, 2010 · Dental

Device Facts

• Record ID: K092772
• Device Name: PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
• Applicant: Hanjin Digi-X Co., Ltd.
• Product Code: EHD · Dental
• Decision Date: Jan 6, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Portable X-ray System (Model: HAND-RAY) 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.

Device Story

Portable dental X-ray system; handheld enclosure containing X-ray generator, controller, and beam-limiting device. Powered by rechargeable 24V DC Li-Polymer battery. Operates by converting DC to AC via high-frequency inverter to generate X-rays; X-rays penetrate tooth and jaw to create images on intraoral receptors (film or digital sensor). Used in dental clinics by dentists or technicians. User interface allows selection of tooth region, patient type (adult/child), and receptor type (film/sensor). Provides diagnostic images for tooth and jaw assessment. Benefits include portability and reduced radiation exposure compared to traditional systems.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 standards established safety and performance equivalence to predicate devices.

Technological Characteristics

Portable handheld X-ray system; 24V DC Li-Polymer battery power; high-frequency inverter; 60kV/2mA fixed output; 0.02-1.8s exposure time; 20cm source-to-skin distance; 6cm cone diameter. Complies with IEC 60601-1, 60601-1-2, 60601-2-7, 60601-2-28, 60601-2-32.

Indications for Use

Indicated for use by trained dentists and dental technicians as an extraoral X-ray source for producing diagnostic images of the tooth and jaw in adult and pediatric patients using intraoral image receptors.

Regulatory Classification

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.

Predicate Devices

• Portable X-Ray System (Model: PORT-X II) (K063121)
• Portable X-Ray System (Model: DIOX-602) (K082167)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Digi-X, with the words "Digi-X" in large, bold, black letters. Below the logo, in smaller letters, is the text "Dental IT Ubiquitous System". The logo is simple and modern, with a focus on the company's name.

K.092772

## Exhibit 5 510(k) Summary

Portable X-Ray System / Model: HAND-RAY

| 1. | Submitter and US Official Correspondent | 'JAN - 6 2010 |
|----|-----------------------------------------|---------------|
|----|-----------------------------------------|---------------|

| Submitter: | Hanjin Digi-X Co., Ltd. |
|-------------------------|---------------------------------|
| Address: | #1101, Acetechno 10th |
| | 470-5, Gasan-dong, Geumcheon-gu |
| | Seoul, 153-789, Korea |
| Official Correspondent: | Shin Kuk Yoo, Consultant |
| Telephone No.: | 714-313-7442 |
| Fax No.: | 801-303-7455 |
| Email: | [e-mail] |

- 2. Establishment Registration Number The firm will be registered and listed prior to distribution of medical device.
## 3. Device Information

| Proprietary/Trade Name: | Portable X-Ray System (Model: HAND-RAY) |
|-------------------------|-----------------------------------------|
| 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 |

## 4. Equivalent Legally Marketed Device

| Predicate #1 | |
|-----------------|--------------------------------------------------------------------------------|
| 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<br>CFR 872 1800 |

# Predicate #2

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Manufacturer: DIGIMED Co., Ltd. Device Name: Portable X-Ray System (Model: DIOX-602) K082167 (Decision Date - Sep. 26, 2008) 510(k) Number: Extraoral Source X-Ray System: EHD, Class II per regulation 21 Classification: CFR 872.1800

#### 5. Description of the Device

The Portable X-ray System (Model: HAND-RAY) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger.

The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that Xray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor).

The Portable X-ray System (Model: HAND-RAY) 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 image receptors.

Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: HAND-RAY).provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.

#### Indications for use റ.

The portable X-ray system (Model: HAND-RAY) 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 HAND-RAY 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. EMC test was performed by SGS Testing Korea Co., Ltd. for HAND-RAY in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements.

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## 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 Equivalence Chart

| Company name | Hanjin Digi-X Co. | GENORAY Co. | DIGIMED Corp. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | HAND-RAY | PORT-X II | DIOX-602 |
| 510(k) No | New | K063121 | K082167 |
| Energy Source | Rechargeable 24V, DC<br>Lithium polymer battery<br>pack | Rechargeable 22.2V DC<br>Lithium polymer<br>battery pack | Rechargeable 24V, DC<br>Lithium polymer battery<br>pack |
| Expose time | 0.02~1.8 seconds,<br>0.01 sec. increments | 0.01~2.0 seconds<br>0.01 increments | 0.01-1.6 seconds, 0.01<br>increments |
| Time accuracy | ±(10% +1ms) | ±(10% +1ms) | ±(10% +1ms) |
| mA | 2mA fixed | 2mA fixed | 2mA fixed |
| kVp | 60kV fixed | 60kV fixed | 60kV fixed |
| Wave form | Constant Potential(DC) | Constant Potential(DC) | Constant Potential(DC) |
| Safety, EMC and<br>performance | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-7<br>IEC 60601-2-28<br>IEC 60601-2-32 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-7<br>IEC 60601-2-28<br>IEC 60601-2-32 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-7,<br>IEC 60601-2-28,<br>IEC 60601-2-32 |
| Source to<br>skin distance | 20cm | 20 cm | 20cm |
| Cone diameter | 6cm | 7 cm | 6.5 cm |
| User Interface | Exposure time:<br>up, down<br>selection of parts of teeth,<br>adult and<br>child, film and<br>sensor with display | Exposure time:<br>up, down<br>Selection buttons of parts<br>of teeth, adult and child,<br>film and sensor with<br>display | Exposure time:<br>up, down<br>Two buttons for<br>modes and<br>selection of parts of teeth,<br>adult and<br>child, film and<br>sensor with display |
| Exposure switch | Control panel and<br>remote controller | Control panel and<br>remote controller | Control panel and<br>remote controller |
| Tube head mounting | Yes | Yes | Yes |
| Intended use | Intended to use by trained dentists and dental technicians as an extra-oral x-ray<br>source for producing diagnostic x-ray images using intra-oral image receptors. Its use<br>is intended for both adult and pediatric subjects. | | |

g.

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### 10. 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 Hanjin Digi-X Co., Ltd., believes that the portable X-ray system (Model: HAND-RAY) is safe and effective and substantially equivalent to the predicate devices, PORT-X II and DIOX-602.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Hanjin Digi-X Co., Ltd. % Mr. Shin Kuk Yoo Consultant LSK BioPartners, Inc. 215 S. Street, Ste 100B SALT LAKE CITY UT 84111

JAN - 6 2010

Re: K092772

Trade/Device Name: Portable X-Ray System (Model: Hand-Ray) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: November 27, 2009 Received: December 2, 2009

Dear Mr. Shin Kuk 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. Iisting 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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit 4

Indications for Use

510(k) number (if known):

Device Name: Portable X-Ray System (Model: HAND-RAY) Indications for Use:

> The Portable X-ray System (Model: HAND-RAY) 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 _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,

(Division Sign-On)
Division of Reproductive, Abdomina and Radiological Devices 510(k) Number