AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY

{0}------------------------------------------------ MAY 2 7 2011 K 111330. Image /page/0/Picture/2 description: The image shows the logo for SKANRAY TECHNOLOGIES. The logo features a cluster of black circles on the left side, resembling a stylized atom or a group of particles. To the right of the circles, the word "SKANRAY" is written in bold, black capital letters. Below "SKANRAY", the word "TECHNOLOGIES" is written in smaller, black capital letters. PRE-MARKET NOTIFICATION 510 (K) SUBMISSIONS-Section 5: Summary for Air Techniques High Frequency Intra-Oral X-Ray Document #: TDS-000004-2-20, Rev#:1 ### 510(K) SUMMARY As required by CFR section 807.92(c) Sponsor 5.1 | Date: | April, 06, 2011 | |-----------------|--------------------------------------| | Applicant: | Skanray Technologies Private Limited | | | Plot # 15-17, Hebbal Industrial Area | | | Mysore-570016, India | | Contact Person: | Parasuramappa Belur | | Telephone: | +91-821-2415559 | | Fax: | +91-821-2403344 | # 5.2 Initial Distributor/ Importer: | Address: | Air Techniques Inc,<br>1295 Walt Whitman Road,<br>Melville, NY 11747-3062 | |------------|---------------------------------------------------------------------------| | Telephone: | 001-516-214-5541 | | Fax: | 001-516-433-7683 | ## 5.3 Establishment Registration Number The firm will be registered and listed prior to distribution of medical device. ### 5.4 Device Name | Trade Name | Air Techniques High Frequency Intra-Oral X-Ray | |---------------------|----------------------------------------------------------------------------------------------| | Variants | Wall, Chair Mount & Floor Stand Identified by Part number<br>303-000134-X where, X= 6 to 11. | | Common Name | High Frequency Intra Oral X-Ray System, | | Classification Name | 76 EHD - Unit, X-Ray, Extra oral with Timer | #### 5.5 Predicate Device | INTRA SKAN DC | K103579 | |------------------|----------| | Progeny PREVA | K043092 | | Dentsply Gx-770: | K935046. | | Gendex 765DC: | K992610. | ## 5.6 Product Description INTRA SKAN DC Variant Part number 303-000134-X is same as private labelled under Air Techniques High Frequency Intra-Oral X-Ray. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Skanray Technologies. The logo features a cluster of dots arranged in a semi-circular shape on the left side. To the right of the dots is the word "SKANRAY" in bold, stylized letters, and below that is the word "TECHNOLOGIES" in smaller, less bold letters. PRE-MARKET NOTIFICATION 510 (K) SUBMISSIONS-Section 5: Summary for Air Techniques High Frequency Intra-Oral X-Ray Document #: TDS-000004-2-20, Rev#:1 Air Techniques High Frequency Intra-Oral X-Ray is an 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 man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output. Air Techniques High Frequency Intra-Oral X-Ray 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 Scissor arm Optional Components: Long Cone 11.8in (300mm) 9.84 Ft (3m) coiled cord with exposure switch The Power supply is regulated to provide a selectable 50 to 70 kVp in step of 1kV at a selectable tube current of 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 kV, mA & exposure time values may be stored in, selected & operated via the operator control panel. # 5.7 Indications for Use Air Techniques High Frequency Intra-Oral X-Ray is to be used as an extraoral source of X-Rays in Dental radiography ### 5.8 Safety, EMC and Performance Data 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, IEC 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 performed according to FDA 21 CFR 1020.30, 21CFR1020.31 standards, Design Requirement specification, verification and validation plans. 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 details combine to demonstrate that the Air Techniques High Frequency Intra-Oral X-Ray is safe and effective when the device is used as labelled. #### END OF DOCUMENT Section 5-2 of 2 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a caduceus-like symbol with three wavy lines representing the branches of government, and the words "USA" are included in the circular text. #### 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 c/o Mr. Morten Christensen Reviewer/Staff Engineer Underwriters Laboratores Inc. 455 East Trimble Road SAN JOSE CA 95131 MAY 2 7 2011 Re: K111330 Trade/Device Name: Air Techniques High Frequency Intra-Oral X-Ray Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: EHD Dated: May 6, 2011 Received: May 11, 2011 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 {3}------------------------------------------------ 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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 {4}------------------------------------------------ ### Indications for Use 510(k) Number (if known): __ Device Name: Air Techniques High Frequency Intra-Oral X-Ray Indications For Use: Air Techniques High Frequency Intra-Oral X-Ray is to be used as an extraoral source of X-Rays in Dental radiography. Prescription Use __ V (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 Device Evaluation (ODE) Mary Slsted (Division Sign Off) :fice of In Vitro D K 111330 510K Page 1 of