RADIOVISION

{0}------------------------------------------------ KIIIIIO2 P. 1 of 3 #### 510(k) SUMMARY MAY - 5 2011 ## General Information | Submitted by: | Haas Software<br>6233 Paso Los Cerritos<br>San Jose, CA 95120<br>Phone: (888) 245-5214 | |-----------------|--------------------------------------------------------------------------------------------------------------| | Contact Person: | Eric H Smith<br>6233 Paso Los Cerritos<br>San Jose, CA 95120<br>Phone: (888) 245-5214<br>Fax: (408) 378-5354 | | Date Prepared: | Dec 8, 2010 | #### Device Information | Trade Name: | RadioVision | |----------------------|---------------------------------------------| | Common Name: | Picture archiving and communications system | | Classification: | Class II | | Classification Name: | System, Image Processing, Radiological | | Reference: | 21 CFR 892.2050 | ## Predicate Device Manufacturer: Gendex Dental Systems Product Name: VixWin Pro 510(k) No. K060178 ### Device Description RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images. Records are stored in a SQL database, searchable by any of the database table column names. The database stores basic patient information and digital image data without compression. Basic image enhancement information is also stored to the database so that the images can be {1}------------------------------------------------ KIIIIOZ P. 2 of 3 re-displayed at a later time with enhancements applied, without altering the original image data. Images may be assembled into layouts which can be customized as required. RadioVision includes standard enhancements such as brightness, contrast, sharpening and false color. Additional advanced controls are also available such as histogram equalization and the CrystalView and Highlight filters. RadioVision includes an automatic backup feature that allows the database to be backed up once each day at a specific time, and will create time-stamped copies of the database so that one can return to a specific point in time. Radio Vision also includes the ability to restore a previously created database backup. #### Intended Use Radio Vision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images. #### Safety Information, comparison to predicate device A Hazard Analysis was performed for RadioVision, which led to the development of Software Requirement Specifications (SRS). The SRS was used to develop a Verification & Validation (V&V) plan executed through a series of Test Cases. The V&V testing was passed, demonstrating that RadioVision performs as indicated. | | Pre-Market Notification | Predicate Device | |---------------------------|------------------------------|------------------| | | Haas Software<br>RadioVision | VixWin Pro | | General Information | | | | 510(k) Number | Not yet assigned | K060178 | | Regulatory Classification | Class II | | | Features | | | | Implementation | Software Only | Software Only | | Host Platform | Mac OS | PC | | USB Support | YES | YES | | X-Ray Sensor Capture | YES | YES | | Enhance Images | YES | YES | | Store and Recall Image | YES | YES | | Intra-Oral camera capture | YES | YES | #### Conclusion {2}------------------------------------------------ KIIIOZ P. 3. of 3 The information contained in this Pre-market Notification is sufficient to demonstrate that RadioVision functions as described, and is substantially equivalent to the VixWin Pro software manufactured by Gendex Dental Systems. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a clear, sans-serif font. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002 Haas Software % Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062 MAY - 5 2011 Re: K111102 Trade/Device Name: RadioVision Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2011 Received: April 20, 2011 Dear Mr. Devine: 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 enclosedly 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 provisions of the Pederal Food, Drug, You may, therefore, market the designed of a premarket approval application (PM 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 misting 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 including, but must CFR Part 807); lebeling (21 CFR D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting (reporting of {4}------------------------------------------------ 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 5100k) remarket 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 Patel 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 {5}------------------------------------------------ # 1. Indications for Use Statement ## Indications for Use Form 510(k) Number (if known): Device Name: RadioVision Indications for Use: RadioVision is a Macintosh-based image management database, or system used primarily by dentists to acquire, archive, display, enhance, print, email, and import/export digital images. Prescription Use × (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 OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Mary Platt Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K111102 Page 1 of _1__ . (.l しゃ |