COMPUTED RADDIOGRAPHY SCANNER

{0}------------------------------------------------ This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date prepared: June. 20, 2010 1. Company and Correspondent making the submission: Name - 3D Imaging & Simulations Corp. Address - 815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea Telephone - +82-42-931-2100 Fax - +82-42-931-2299 Contact - Jiin Jung / Vice President E-mail - jiinjung@3-disc.com - 2. Device : Trade/proprietary name : FireCR Common Name : Computed Radiography Scanner Classification Name : Solid-State X-ray Imaging system 3. Predicate Devices : | Manufacturer | : AGFA Corporation | |---------------|------------------------------------------| | Device | : ADC Compact Plus | | 510(k) Number | : K013138(Decision Date - Sep. 28, 2001) | ### 4. Classifications Names & Citations : 21CFR 892.1650, MQB - Solid-State X-ray Imaging system, Class 2 #### 5. Description : #### 5.1 General The FireCR is Computed Radiography System which produces the X-ray diagnostic image in digital formation wasn't broutinnal screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat flelding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused. #### 5.2 Main Features #### Scanning Mechanism FireCR employs a scanning mechanism using swing mirror to construct its compact and rigid structure. {1}------------------------------------------------ High Throughput lts unique and patented dual direction scanning mechanism enables to improve the efficiency and high throughput. Scanning Resolution User selectable resolution of 100μm and 200μm allows user to make diagnosis on variable purposes. Detector High sensitive photomultiplier tube equlpped in FireCR delivers high gain, wide dynamic range and high speed response for radiographic imaging. Powerful Acquisition and Diagnostic Software QuantorMed Acquisition and Diagnostic Software is supplied with every FireCR, and Its accurate and rapid data processing make the scanner more powerful. 5.3 Product features - Photomultiplier Tube : (PMT) - 14" x17" imaging area. - Wide dynamic range with 16-bit digitization - Image process parameters are selectable according to the body part to make best images for diagnosis - DICOM3.0 standard compliance - Image Format : 3500 x 4300 - User Selectable Scanning Resolution : 100um and 200um 6. Indications for use : This device is a Computed Radiography Scanner and intended for use in producing digital X-Ray lmages for general radiography purposes. It comprises of scanner, cassette with reusable imaging plate and workstation software. It scans X-Ray exposed image plate and produces X-Ray lmage in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not approved for the acquisition of mammographic image data. 7. Comparison with predicate device : 3D Imaging & Simulations Corp. believes that the Computed Radiography Scanner (FireCR) is substantially equivalent to ADC Compact Plus of AGFA Corporation. 8. Safety, EMC, Biocompatibility and Performance Data : Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory. - 9. Conclusions : In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification 3D Imaging & Simulations Corp. concludes that the Digital Radiography System(FireCR) is safe and effective and substantlally equivalent to predicate devices as described herein. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a blue graphic on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The graphic is a stylized representation of a human figure, and the text is in a sans-serif font. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 3DISC Americas % Mr. Daniel Kamm, P.E. Submission Correspondent Kamm & Associates 8870 Ravello Court NAPLES FL 34114 AUG 2 3 2013 Re: K102619 Trade/Device Name: Computed Radiography Scanner/FireCR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: March 1, 2011 Received: March 3, 2011 Dear Mr. Kamm: This letter corrects our substantially equivalent letter of May 13, 2011. 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 requirenceds as set form in the quality of the as described in your Section 5100k) premarket will allow you to begin marketing your device of your device to a legally marketed nothication. The FDA inding of Saccian 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 CFF Parts 801 and II you desire specific advice for your device of the riseenig cover in the first of the may of 607), prease vonaot the regulation entitled, "Misbranding by reference to premarket 1450. Also, please note the regarding the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (21 CF RT at 800), promo goblem/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 Tour may 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, Janine M. Morris Acting 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): K10 Device Name: Computed Radiography Scanner / FireCR Indications for Use: This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette willta reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transforred to workstation for further processing and routing. This device is intended to be aneroned in a radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data. Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1 Tad D. O'Hern (Division Sign-Off) (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 14 810K K102619 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, rendered in blue. The eagle's wings are curved and flowing, giving the impression of movement. # DEPARTMENT OF HEALTH & HUMAN SERVICES ### MEMORANDUM Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Date: August 15, 2012 From: William C. Jung To: The Record Subject: Reassignment of Regulation Number for MQB > 510(k) K102619, Computed Radiography Scanner/FireCR was originally assigned a Product Code of MQB (solid state x-ray imager (flat panel/digital imager) under regulation number, 21 CFR 892.1650, image-intensified fluoroscopic x-ray system. The Product Code MQB is being reassigned under 21 CFR 892.1680.