FLAT PANEL DETECTOR, MODEL FDR D-EVO

{0}------------------------------------------------ # 100762 Image /page/0/Picture/1 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the main logo, the text "Fujifilm Medical Systems, USA" is written in a smaller font. The logo appears to be a standard corporate logo, likely used for branding and identification purposes. JUL 1 5 2010 ## 510(k) Summary for FDR D-EVO Flat Panel Detector ## Date: March 16, 2010 ## Contact Person: | Name: | | |------------|--| | Title: | | | Telephone: | | | Facsimile: | | Debbie Peacock Regulatory Coordinator (203) 602-3774 (203) 363-3813 ## Identification of Device: Proprietary/Trade Name: Classification Name: Classification: CFR Section: Product Codes: Common Name: FDR D-EVO (DR-ID600) Solid State X-ray Imager (Flat Panel/Digital Imager) Panel: Radiology 21 CFR 892.1650 90 MQB Flat Panel Digital Detector #### l. INDICATIONS FOR USE The FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO is not intended for mammography. #### 11. DEVICE DESCRIPTION FDR D-EVO flat panel detector is an indirect-conversion amorphous silicon (a-Si) portable flat panel detector (FPD) utilizing GOS (Gadolinium OxySulfide) as a schifillator. FDR D-EVO detector has Fuji's unique Irradiation Side Sampling system, delivering high image quality. D-EVO's 14x17" standard cassette size affords it the ability for use as a retrofit in any analog bucky and/or as an additional panel with fixed digital radiography systems, allowing a quick conversion to digital X-ray technology. The D-EVO features a detachable power source that enables easy positioning within the radiographic room within an upright bucky, table or as a free cassette. Data captured via operator console is sent electronically to the Fujifilm FDX Console to be displayed on the peraitor. #### lll. SUMMARY OF STUDIES Fujifilm's D-EVO Flat Panel Detector successfully completed internal and international IEC testing requirements. In addition, Fujifilm performed an image quality reader study on 30 image pairs comparing the FDR D-EVO system with the cleared Fujifilm Carbon XL-2. Three board certified radiologists reviewed the images as described below. {1}------------------------------------------------ # Fujifilm Medical Syste Analysis Methodology: All images must be deemed to be of diagnostic capability. In addition, the study will be considered a success if at least 90% of the scores from the D-EVO system are greater than or equal to -1. ### Results: All images were deemed to be of diagnostic capability, in addition, all readers satisfied the success criteria with 100% of the D-EVO image scores greater than or equal to -1. Test Protocol and Results are enclosed as Attachments H and I. #### IV. SUBSTANTIAL EQUIVALENCE The Fujifilm FDR D-EVO Flat Panel Detector is substantially equivalent to the following currently cleared device: | Predicate Device | 510(k) # | |----------------------|----------| | Canon CXDI-55G | K091435 | | Carestream DRX-1 | K090318 | | Fujifilm Carbon XL-2 | K042023 | The proposed and predicate devices utilize similar technology and materials, comparable safety and effectiveness features, and are similar in design and construction. The Indications for Use and labeling are virtually the same, or similar and our labeling contains the required Cautions, Warnings and Contraindications consistent to those required for similar cleared devices .. The FDR D-EVO and the predicate Canon CXDI-55G detector are both portable, digital indirect conversion, amorphous silicon (a-Si), wired GOS detectors used for the same application, to image general radiographic examinations, excluding mammography. The Carestream DRX-1 detector is a portable, digital indirect conversion, amorphous silicon (a-Si), wireless GOS detectors used for the same application, to image general radiographic examinations, excluding mammography. All systems produce digital images which can be sent to hardcopy printers, softcopy diagnostic workstations and/or stored in archive. Fujifilm Carbon XL-2 reads the x-ray image from cassette based photostimuable phosphor plates and converts it to a digital image. The FDR D-EVO FPD is used to directly capture digital X-ray images. Both systems use an acquisition workstation to display the acquired images and transmit them via network connection for diagnostic viewing and printing. #### V. CONCLUSION The FDR D-EVO Flat Panel Detector is substantially equivalent to the cleared predicate detectors and conforms to applicable medical device safety standards {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure or a caduceus. The text is in a sans-serif font and is colored in blue. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Ms. Debra A. Peacock Senior Regulatory Affairs Specialist FUJIFILM Medical Systems, USA Inc. 419 West Avenue STAMFORD CT 06902 AUG 2 3 2013 Re: K100762 Trade/Device Name: FDR D-EVO (DR-ID 600) Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 17, 2010 Received: May 18, 2010 Dear Ms. Peacock: This letter corrects our substantially equivalent letter of July 15, 2010. 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. Iisting 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, Janine M. Morris Janine M. Morri 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): K100762 ## Device Name: __ FDR D-EVO (DR-ID 600) Flat Panel Detector Indications for Use: 0 The FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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) hnd D. O'th (Division Sign-Off) (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety 510K K100762 Page 1 of