DX-D 600

{0}------------------------------------------------ OCT 2 7 2011 ## 510(K) SUMMARY: AGFA DX-D 600 Common/Classification Name: Stationary System, 21 CFR 892.1680 Proprietary Name: DX-D 600 Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Deigiain Contact: Phil Cuscuna, Prepared: August 26, 2011 Telephone: (416) 240-7317 Facsimile: (416) 240-7359 #### LEGALLY MARKETED PREDICATE DEVICES A. This is a 510(k) for Agfa's DX-D 600, a stationary x-ray system that includes previously cleared digital image capture equipment. #### DEVICE DESCRIPTION B. The device is a conventional x-ray system with digital image capture equipment. The device wall The device is a combination of convenibian sear system with andor wall and/or wall new device is a ceiling mounted tube and operation artible AFT LC A 3M image procession new device is a celling mounted the operator with workstation with MUSICA A"M image processing stand. The DX-D 600 uses Agfa's rillian dust attested that Cosius Indice or Ga stand. The DX-D 000 uses Agra 3 tillinia Tri-Protodetector type (Cesum Iodide on Gadolinium and flat panel detectors of the scintillator-photodecaters as well and frat panel delectors of the Semmator parties. Oxysulfide). It is compatible with Agfa's computed radiography systems as well. Chycation of operation and technological characteristics of the new and predicate devices are the same. #### INTENDED USE C. The DX-D 600 system is indicated to make static X-ray radiographic images of the skeleton (including I he DA-D 000 system is marcated to mast and other body parts. Applications can be performed with the patient in the sitting, standing or lying position. This device is not intended for use in mammography. #### SUBSTANTIAL EQUIVALENCE SUMMARY D. Agfa's DX-D 600 has an Indications For Use statement nearly identical to the statements for the predicate Agfa's DX-D 600 has an indications i of USC statement nears have the same technological device, Agta's DX-D 500. Intended uses are the same. "The device and are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect. {1}------------------------------------------------ K 112670 2043 | PRODUCT COMPARISON TABLE | | | |--------------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | | AGFA DX-D 600<br>(NEW DEVICE) | AGFA DX-D 300<br>(PREDICATE-K103050) | | Communications | Same as predicate | DICOM | | Detector Material | Same as predicate | Gadolinium Oxysulfide (GOS) or Cesium<br>Iodide (CSI) scintillator | | Detector Sizes | Same as predicate | 43x43 cm (17x17 in.)<br>43x35 cm (14x17 in.) | | Active Matrix | Same as predicate | 3072x3072<br>3072x2560 | | Pixel size | Same as predicate | 139 um | | Fill factor | Same as predicate | 100% | | Dynamic Range | Same as predicate | 14 bit DR. 12 bit CR | | Image processing | Same as predicate | MUSICA2 | | Operating system | Same as predicate | Windows XP Pro | | Display System | Same as predicate | Standard PC display or separately cleared<br>medical display (e.g. K051901) | | Operator Workstation | Same as predicate | Agfa NX with x-ray soft console | | Power Supply | Three phase, 50/60 Hz<br>380/400/415/440/480 v ±10% | 230 / 240 v, 50/60 Hz , ±10%<br>Generator: Three phase, 50/60 Hz<br>380//480 v ±10% | | Electrical Safety | Same as predicate | IEC-60601 | | Performance Standard | Same as predicate | 21CFR1020.30 | | Generators | Choice of four models: 32 - 80 KW | Choice of four models. 50-80 KW | | Tubes | Toshiba models: E7252X, E7254X,<br>E7869X. E7884X | Toshiba models: E7254FX, E7869X &<br>E7884X. | | Collimation/AEC | Same as predicate | Automatic or manual collimation,<br>integrated Dose Area Product (DAP)<br>meter and automatic exposure control<br>(AEC) | #### E. TECHNOLOGICAL CHARACTERISTICS Agfa's DX-D 600 is a traditional ceiling mounted x-ray system for patient exposure and digital image capture. The x-ray system includes one of four 32-80 kW generators and one of four Toshiba x-ray tubes. A patient table and wall stand are available. Tube rotation, height, source-to-image distance and detector rotation are controlled by motors at the ceiling suspension unit. The operator must be present at the unit to enable motion. Cesium Iodide or Gadolinium Oxysulfide flat panel detectors are used to capture images. Previews on the NX workstation are available to the operator in as little as one vecond after exposure. MUSICA 2TM image processing provides consistent image quality. DICOM connectivity allows images to be directed to the user's PACS system, archive or hord copy printer. The system is also compatible with Agfa computed radiography systems. {2}------------------------------------------------ K 112676 Page 3 of 3 ### TESTING F. . TESTING The product has been tested and shown to conform to electronic medical product safety, The product and showling standards including: The product has been tested and standards including: radiology, and medical imaging standards including: # PRODUCT STANDARDS - ODUCT STANDARDS IEC 60601-I-I : Medical electrical equipment Part I : General requirements and essential IEC 60601-1-1: Medical electrical equipment - Part 1: Gellerismants and tests. performance, plus collateral standard: Electronagenic compatibility - requirements and tests. P . - IEC 6000 P-1 Precious Part I-2: Ceneral Requirements For Safety Fequirements For Safety Collection performance, plus collateral equipment Part I-2: General Requiremen IEC 60601-1-2: Medical electrical equipment - essent - ests - ests - Standard: Electromagnetic And Tests Standard: 2001-2004-2-18: Digitel Imaging and Communications in N . - 12 Compatible Compatibulity Requirences raia von Medicine (DICOM) ACR/NEMA PS3.1-3.18: Digital Imaging and Communications in Medicine (DICOM) Constant (Calleria) (Catrico Standard: Lietuvolagious - . - IEC 60601-1-3: Medical electrical equipment Far 11 Someon Processor (1) General requirements for radiation protection in diagnostic X-ray equipment . # MANAGEMENT STANDARDS NAGEMENT STANDARDS ISO 14971 Application of Risk Management to Medical Devices Online Management Online One Overity Management Systems - Re NATION - OFF ISO 14971 Application of Risk Management to Medical Devices ISO 14971 Application of Risk Management Systems - Requirements For Regulatory purposes ISO 13485 Med . - t An image quality evaluation has been conducted comparing images from the new device to the f or and and started any a bous been provided. An image quality evarantaneers have been provided. predicated. Performance of the complete system has been validated. Performance of the comparism of the development of the DX-D 600. ## CONCLUSIONS G. CONCLUSIONS This 510(k) has demonstrated Squivalence as defined and understood in the Federal Food This 510(k) has demonstrated Substantial Equivalence as defined and alsortes and and Radiological Health. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. ### 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 OCT 2 7 2011 Agfa Healthcare. N.V. % Mr. Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW BUFFALO MN 55313 Rc: K112670 Trade/Device Name: DX-D 600 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: October 17, 2011 Received: October 20, 2011 Dear Mr. Job: 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 {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 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 1 809), 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}------------------------------------------------ ## Indications for Use Form K112670 510(k) Number (if known): Device Name: DX-D 600 ### Indications for Use: The DX-D 600 system is indicated to make static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. Applications can be performed with the patient in the sitting, standing or lying position. This device is not intended for use in mammography. Prescription Use X (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 S. Patil Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K112670 Page 1 of |