PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX

K082167 · Digimed Corporation · EHD · Sep 26, 2008 · Dental

Device Facts

• Record ID: K082167
• Device Name: PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
• Applicant: Digimed Corporation
• Product Code: EHD · Dental
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Portable X-ray System (Model: DIOX-602, PROX) 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; hand-held enclosure containing X-ray generator, controller, and beam-limiting device. Operates on 24VDC via rechargeable Li-Polymer battery. Input: manual settings for exposure time, tooth region, patient age (adult/child), and receptor type (film/sensor). Principle: high-frequency inverter converts DC to AC to drive X-ray tube; X-rays penetrate tooth/jaw to create images on intraoral receptors. Used in dental clinics by dentists or technicians. Output: X-ray beam for diagnostic imaging. Benefits: provides sharp images while minimizing radiation exposure to patients and operators. Includes remote controller for exposure switching.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and performance evaluation, including compliance with IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 standards.

Technological Characteristics

Portable hand-held dental X-ray system. Energy source: 24VDC rechargeable Li-Polymer battery. High-frequency inverter technology. Fixed output: 60kVp, 2mA. Exposure time: 0.01-1.6s. Source-to-skin distance: 20cm. Compliance: UL/IEC 60601-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, and EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for use by trained dentists and dental technicians as an extraoral X-ray source for diagnostic imaging of teeth and jaws 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

• PORT-X II (K063121)

Submission Summary (Full Text)

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K082 167

Image /page/0/Picture/1 description: The image contains the word "DigiMed" in a stylized font. To the left of the word is an oval shape that is divided into sections of varying shades of gray and black. The text is in a bold, slightly italicized font, giving it a modern and professional appearance. The overall composition is simple and clean, with a focus on the text and the abstract oval shape.

SEP 2 6 2008

# 5 510(k) Summary

#### 5.1 Company and Correspondent Making the Submission:

| Date Prepared: | June 16, 2008 |
|----------------|------------------------------------------------------------------------------------------------|
| Name: | DIGIMED Corporation |
| Address: | #715, World Meridian Venture Center II, 426-5 Gasan-Dong<br>Gumcheon-Gu, Seoul, 153-803, Korea |
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact: | Youngbae Kwon, Managing Director |

: 上一篇:

#### 5.2 US Agent for FDA Contact:

| Name: | Shin Kuk Yoo |
|----------|----------------------------|
| Company: | LSK BioPartners, Inc. |
| Address: | 215 S. State St. STE100B |
| | Salt Lake City, Utah 84111 |
| Tel: | 801-303-7440 (Ext. 202) |
| Fax: | 801-303-7455 |
| Email: | [e-mail] |

#### 5.3 Device Information:

. ...

.

| Proprietary-Trade Name: | Portable X-Ray System (Models: DIOX-602, PROX) |
|-------------------------|----------------------------------------------------------------------------|
| Classification Name: | Extraoral Source X-Ray System: EHD, Class II per regulation 21CFR 872.1800 |
| Common/Usual Name: | Portable X-Ray System |

| Manufacturer: | GENORAY Co., Ltd. |
|-----------------|----------------------------------------------------------------------------|
| Device: | Portable X-Ray System (Model: PORT-X II) |
| Classification: | Extraoral Source x-Ray System: EHD, Class II per regulation 21CFR 872.1800 |
| 510(k) Number: | K063121 (Decision Date: Jan. 11, 2007) |

:

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#### 5.5 Indications for Use (Intended Use):

The Portable X-ray System (Model: DIOX-602, PROX) 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.

#### 5.6 Description of Device

The Portable X-ray System (Model: DIOX-602, PROX) 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 X-ray 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: DIOX-602, PROX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral xray 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: DIOX-602, PROX) provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.

#### 5.7 Safety and Effectiveness, Comparison to Predicate Device:

The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices.

#### 5.8 Safety, EMC and Performance Data:

The portable x-ray system, DIOX-602 and PROX, will comply with 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 testing was conducted by EMC Compliance Co., Ltd. for DIOX-602 and SGS Testing Korea Co., Ltd. for PROX in accordance with Standard EN/IEC 60601-1-2. All test results were satisfactory.

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#### 5.9 Substantial Equivalence Chart

| Company | GENORAY Co. | DIGIMED Corp. | |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Model | PORT-X II | DIOX-602 | PROX |
| 510(k) No | K063121 | New | |
| Energy source | Rechargeable 22.2V<br>DC Lithium Polymer<br>battery pack | Rechargeable 24V, DC Lithium Polymer Battery pack | |
| Expose time | 0.01-2.0 seconds<br>0.01 increments | 0.01-1.6 seconds, 0.01 increments | |
| Time accuracy | $\pm$ (10%+1ms) | $\pm$ (10%+1ms) | |
| mA | 2mA fixed | 2mA fixed | |
| kVp | 60kV fixed | 60kV fixed | |
| Wave form | Constant Potential (DC) | Constant Potential (DC) | |
| Safety, EMC and<br>performance | IEC 60601-1, IEC 60601-<br>2-7<br>IEC 60601-2-28,<br>IEC 60601-2-32 | IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28,<br>IEC 60601-2-32 | |
| Source to skin<br>distance | 20cm | 20cm | |
| Cone diameter | 7Cm | 6.5 Cm | 6 Cm |
| User Interface | Exposure time: up, down.<br>Selection buttons of parts<br>of teeth, adult and child,<br>film and sensor with<br>display. | Exposure time: up, down.<br>Two buttons for modes<br>and selection of parts of<br>teeth, adult and child,<br>film and sensor with<br>display. | Exposure time: up, down.<br>Selection<br>buttons of parts of<br>teeth, adult and child,<br>film and sensor with<br>display. |
| Exposure switch | Control panel and<br>remote controller | Control panel and remote controller | |
| Tube head<br>mounting | 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 or<br>film. It is intended to use for both adult and pediatric subjects. | | |

### 5.10 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided the above comparison table, the DIGIMED Corporation concludes that the portable X-ray System (Model: DIOX-602, PROX) is safe and effective and substantially equivalent to the predicate device as described above.

.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a modern, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 6 2008

DIGIMED Corporation % Mr. Shin Kuk Yoo Business Development Manager LSK BioPartners, Inc. 215 S. State Street, STE 100B SALT LAKE CITY UT 84111

Re: K082167

Trade/Device Name: Portable x-ray system (Models: DIOX-602, PROX) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: July 29, 2008 Received: July 31, 2008

### 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 ffor 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.

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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### Page 2

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 of 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 894.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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours.

hope Mr. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K082167

Device Name: Portable x-ray system (Models: D1OX-602, PROX) Indications for Use:

> The Portable X-ray System (Model: DIOX-602, PROX) 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) -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hw Lewis

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number