INTRA SKAN DC

K103579 · Skanray Technologies · EHD · Mar 18, 2011 · Dental

Device Facts

• Record ID: K103579
• Device Name: INTRA SKAN DC
• Applicant: Skanray Technologies
• Product Code: EHD · Dental
• Decision Date: Mar 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The INTRA SKAN DC Intraoral Dental X-Ray System is to be used as an extraoral source of X-Rays in Dental radiography.

Device Story

INTRA SKAN DC is a high-frequency intraoral X-ray system for dental diagnostic radiography. System components include a base unit, tube housing with integrated beam-limiting device, rotating yoke, extension arm, scissor arm, and control console with exposure switch. Device operates by generating X-rays at selectable 50-70 kVp and 4, 6, 7, or 8 mA settings; exposure times range from 0.04 to 4.00 seconds. Two microprocessors manage control/supervisory functions and user interface. Feedback circuits ensure X-ray output accuracy and reproducibility. Predefined exposure parameters can be stored and selected via the operator control panel. Used in dental clinical settings by dental professionals to produce diagnostic images for patient assessment.

Clinical Evidence

Bench testing only. Performance validated against FDA 21 CFR 1020.30 and 1020.31 standards. Electrical, mechanical, and environmental safety verified per UL/IEC 60601-1, 60601-1-3, 60601-2-7, 60601-2-28, and 60601-2-32. EMC testing performed per IEC 60601-1-2. All test results were satisfactory.

Technological Characteristics

High-frequency intraoral X-ray system. Selectable 50-70 kVp; 4, 6, 7, 8 mA. Exposure time 0.04-4.00s. Duty cycle 1:15. Dual microprocessor control (supervisory and user interface). Feedback circuits for output reproducibility. Standards: UL/IEC 60601-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, IEC 60601-1-2, 21 CFR 1020.30, 21 CFR 1020.31.

Indications for Use

Indicated for use as an extraoral X-ray source for dental diagnostic radiography.

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

• Progeny PREVA (K043092)
• Dentsply Gx-770 (K935046)
• Gendex 765DC (K992610)

Submission Summary (Full Text)

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# K103579.

### 510(K) SUMMARY As required by CFR section 807.92(c)

MAR 1 8 2011

Sponsor 5.1

December 13, 2010

Applicant:

Date:

Skanray Technologies Private Limited, Plot # 15-17, Hebbal Industrial Area Mysore-570016; India Parasuramappa Belur

Contact Person:

Telephone:

Fax:

[phone]

[phone]

### 5.2 Establishment Registration Number

The firm will be registered and listed prior to distribution of medical device.

### 5.3 Device Name

| Trade Name | INTRA SKAN DC |
|---------------------|---------------------------------------------|
| Common Name | High Frequency Intra Oral X-Ray System |
| Classification Name | 76 EHD - Unit, X-Ray, Extra oral with Timer |

#### Predicate Device 5.4

| Progeny PREVA | K043092 |
|------------------|----------|
| Dentsply Gx-770: | K935046. |
| Gendex 765DC: | K992610. |

### 5.5 Product Description

INTRA SKAN DC is a high frequency Intra-oral X-Ray System with an extraoral X-Ray source for dental diagnostic radiography. The system houses two microprocessors, one for control / supervisory functions and another for manmachine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.

INTRA SKAN DC consists of the following main components:

Base Unit

Tube Housing

Beam Limiting Device-inbuilt with tube Housing

Control Console, 9.84 Ft (3 m) coiled cord.

Rotating yoke for tube housing mounting

Extension arm

Section 5-2 of 3

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issor arm Optional Components: Long Cone 11.8in (300mm) 2015 - 13m) coiled cord with exposure switch

The Power supply is regulated to provide a selectable 50 to 70 kVp in step of The Power Supply is regulated to pf 4, 6, 7, or 8 mA. The range of exposure times is 0.04 to 4.00 seconds with 1:15 duty. Predefined exposure parameters ky, mA & times may be stored in, selected & operated via the operator control panel.

#### Indications for Use 5.6

The INTRA SKAN DC Intraoral Dental X-Ray System is to be used as an extraoral source of X-Rays in Dental radiography.

#### Safety, EMC and Performance Data 5.7

Safety and effectiveness is demonstrated by:

- Electrical, mechanical, environmental safety and performance testing according to standard UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, JEC 60601-2-28, and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory. Refer EMC Test Summary & Safety Test Report Summary in section "Electromagnetic Compatibility and Electrical Safety" of this submission document.
- Performance testing according to FDA 21 CFR 1020.30, 21CFR1020.31 standards, Design Requirement specification & verification and validation plans was performed. All test results were satisfactory. Refer summary of performance in section 18 "Performance Testing-Bench" of this submission document.
- Same indications for use as predicate devices.

All of the above steps combine to demonstrate that the INTRA SKAN DC is safe and effective when the device is used as labelled.

### END OF DOCUMENT

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the eagle in a circular pattern. The eagle is facing to the right, and its head is turned slightly towards the viewer. The seal is black and white.

### 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

Skanray Technologies % Mr. Morten Christensen Reviewer/Staff Engineer Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131

Re: K103579

MAR 1 8 201

Trade/Device Name: INTRA SKAN DC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source s-ray system Regulatory Class: II Product Code: EHD Dated: March 2, 2010 Received: March 4, 2010

Dear Mr. Christensen:

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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [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

510(k) Number (if known): ر

Device Name: INTRA SKAN DC

Indications For Use:

The INTRA SKAN DC Intraoral Dental X-Ray System is to be used as an extraoral source of X-Rays in Dental x Tray Uyst

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR*

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

ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Padle
(Division Sign-Off)

Division of Radiological Devices vision of Raulological Donoto
o Diagnostic Device Evaluation and Safety

510K. K103579

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