PORTABLE X-RAY SYSTEM

K103600 · Digimed Corporation · EHD · Apr 8, 2011 · Dental

Device Facts

• Record ID: K103600
• Device Name: PORTABLE X-RAY SYSTEM
• Applicant: Digimed Corporation
• Product Code: EHD · Dental
• Decision Date: Apr 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral 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 (BIOX) generates X-rays for diagnostic imaging of teeth and jaws. Device comprises X-ray generator, controller, and beam-limiting device housed in a hand-held enclosure. Operates on 24VDC via rechargeable Li-Polymer battery or external power supply. High-frequency inverter converts DC to AC for X-ray tube excitation. Used by dentists and dental technicians in clinical settings. Operator selects exposure parameters (tooth type, patient size, receptor type) via control panel; remote controller available. Lead protective seal minimizes leakage radiation. Output is X-ray beam directed at intraoral receptors (film or digital sensor) to produce diagnostic images. Benefits include portability and diagnostic utility for dental assessment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and performance data, including compliance with IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 standards.

Technological Characteristics

Portable hand-held X-ray system. Energy source: 24VDC rechargeable Li-Polymer battery or 24VDC power supply. High-frequency inverter. Lead protective seal for radiation shielding. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32. Fixed 60kVp, 3mA output. Exposure time 0.01-1.6s. Connectivity: None (standalone).

Indications for Use

Indicated for use by trained dentists and dental technicians as an extra-oral X-ray source for diagnostic imaging of teeth and jaws in adult and pediatric patients using intraoral 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)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for DigiMed. The logo consists of two parts: a stylized graphic on the left and the text "DigiMed" on the right. The graphic is an oval shape with three vertical bars inside, and the text "DigiMed" is written in a bold, sans-serif font.

K 103600

APR - 8 2011

# 5 510(k) Summary

.

## 5.1 Company and Correspondent Making the Submission:

| Date Prepared: | June 16, 2008 |
|----------------|--------------------------------------------------------------------------------------|
| Name: | DIGIMED Corporation |
| Address: | #311, ACE HIGH-END TOWER 3, 371-50 Gasan-Dong,<br>Gumcheon-Gu, Seoul, 153-787, Korea |
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Contact: | Youngbae Kwon, Managing Director |

# 5.2 US Agent for FDA Contact:

| Name: | Kim Antol |
|----------|---------------------------------------------|
| Company: | Sigma Digital X-Ray |
| Address: | 1607 Barclay Blvd., Buffalo Grove, IL 60089 |
| Tel: | 847-419-0669 |
| Fax: | 847-419-0675 |
| Email: | [e-mail] |

## 5.3 Device Information:

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

## 5.4 Predicate Devices :

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

## 5.5 Indications for Use (Intended Use):

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The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral 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: BIOX) 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 teeth 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 teeth and jaw, and makes X-ray images on a receptor (chemical film or digital sensor).

The Portable X-ray System (Model: BIOX) 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: BIOX) provides sharp and clear images and protects patients and dentists from leakage radiation by using a lead protective seal.

### 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, BIOX, 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. and SGS Testing Korea Co., Ltd. for BIOX in accordance with Standard EN/IEC 60601-1-2. All test results were satisfactory.

#### 5.9 Substantial Equivalence Chart

$$\mathfrak{g}\cdot\mathfrak{a}\bullet\mathfrak{b}$$

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| Company name | GENORAY Co. | DIGIMED Corp. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Model | PORT-X II | BIOX |
| Intended use | Intended to use by trained dentists and dental technicians as an extra-oral<br>x-ray source for producing diagnostic x-ray images using intra-oral<br>image receptors or film. It is intended to use for both adult and pediatric<br>subjects. | |
| 510k No | K063121 | New |
| Energy Source | Rechargeable 22.2V<br>DC Lithium polymer battery pack | Rechargeable 24V,<br>DC Lithium polymer battery pack<br>Or DC 24V Power Supply |
| Source to<br>skin distance | 20 Cm | 210Cm |
| Cone diameter | 7 Cm | 6Cm |
| Expose time | 0.01~2.0 seconds<br>0.01 increments | 0.01-1.6 seconds,<br>0.01 increments |
| Time accuracy | ±(10% +1ms) | ±(10% +1ms) |
| mA | 2mA fixed | 3mA fixed |
| kVp | 60kV fixed | 60kV fixed |
| Wave form | 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 |
| User Interface | Exposure time: up, down select<br>buttons of parts of teeth, adult and<br>child, film and sensor with display | Exposure time: up, down select<br>buttons of parts of teeth, adult and<br>child, film and sensor with display |
| Exposure switch | Control panel and remote controller | Control panel and remote controller |
| Tube head<br>mounting | Yes | Yes |

## 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 Corpor -ation 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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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal 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

Digimed Corporation % Mr. Kim Antol President Sigma Digital X-Ray 1607 N. Barclay Ave. BUFFALO IL 60089

APR - 8 201

Re: K103600

Trade/Device Name: Portable x-ray system (Models: BIOX) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: March 10, 2011 Received: March 10, 2010

Dear Mr. Antol:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 manketed predicate device results in a classification for your device and thus, permits your dry many proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety of [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K103600 510(k) Number (if known):

Device Name: Portable x-ray system (Models: BIOX)

Indications for Use:

The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral 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 ***_***_ AND/OR

(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)

Mary S Patel

Office of In

510K K103600