SATURN 9000-550

{0}------------------------------------------------ ## 510(K) Summary Image /page/0/Picture/1 description: The image shows handwritten text on a white background. The text "K072984" is at the top, followed by "Page 1 of 2" on the next line. The writing appears to be done with a dark ink pen, and the overall impression is that of a document or record marking. Image /page/0/Picture/2 description: The image shows a large, stylized letter 'N' in black. The letter has a bold, slightly distorted appearance, with a textured or patterned fill. The background is plain and light, providing contrast to the dark letter. ## 1. Date Prepared: October 19th 2007 #### 2. Submitter: | Company Name: | New Medical Co.,LTD. | |------------------|----------------------------------------------------------------| | Company Address: | 4F, No.42, SingZhong Rd., NeiHu District<br>Taipei 114, Taiwan | | Contact Person: | Young-Hoon Shin, Diretor of R&D, yhshin@newmedical.com.tw | | Phone number: | +886-2-8791-6268 | | FAX number: | +886-2-8791-6269 | | NOV 14 2007 | | #### 3. Proposed Device: | Type of the Submission: | Special | |-------------------------|-------------------------------| | Reason For 510(k): | Replacement of the component | | Manufacturer: | New Medical Co.,LTD | | Trade Name: | New Medical | | Model Name: | Saturn 9000-550 | | Regulatory Class: | II | | Classification Name: | MQB, Solid State X-ray Imager | | FDA 510(K) Number: | To be assigned | #### 4. Predicate Device: | Manufacturer: | New Medical Co.,LTD. | |----------------------|-------------------------------| | Trade Name: | New Medical | | Model Name: | Saturn 9000 | | Regulatory Class: | II | | Classification Name: | MQB, Solid State X-ray Imager | | FDA 510(K) Number: | K063710 | 5. Device Description: The Saturn 9000-550 is equipped with a digital detector, X-ray generator interface, and image acquisition workstation. The digital detector is a-Se deposited plat panel detector. The input X-ray photons are absorbed in a-Se layer that creates an electrical charge which is representation of the Xray input. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. X-ray exposure is controlled by switch box, which also controls the acquisition timing of the detector. Saturn 9000-550 includes acquisition workstation ("AWB") monitor, {1}------------------------------------------------ . 703542 Page 11, 2 keyboard and mouse, computer, electronics, and accessory storage. resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming. The Saturn 9000-550 is substantially equivalent to the Saturn 9000. - 6. Indications for Use: The Saturn 9000-550 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-550 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-550 is intended to be used in same clinical application as traditional film-screen based general radiography system. ## 7. Comparison between Predicate Device and Proposed Device | | | Predicate Device<br>Saturn 9000 | Proposed Device<br>Saturn 9000-550 | |----------------------------|-----------------------|---------------------------------|------------------------------------| | Detector | Technology | a-Se, Direct | a-Se, Direct | | | Thickness of Se layer | 450μm | 450μm | | | Imaging Area | 14" X 17" | 47" X 17" | | | Detector Pixel size | 139μm | 168μm | | | Image Bit Depth | 14bits | 14bits | | | Image Data Interface | Camera Link | Camera Link | | Control Box | | | Same as Saturn 9000 | | Switch Box | | | Same as Saturn 9000 | | Image Acquisition software | | DxWorks | DxWorks<br>(Same as Saturn 9000) | | Accessories | | | Same as Saturn 9000 | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure and a globe, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. Young-Hoon Shin Director of R&D New Medical Company, Ltd. 4F, No. 42, SingZhong Road NEIHU DISTRICT TAIPEI TAIWAN AUG 2'3 2013 Re: K072984 Trade/Device Name: Saturn 9000-550 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: October 19, 2007 Received: October 23, 2007 Dear Mr. Shin: This letter corrects our substantially equivalent letter of November 14, 2007. We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered phorts to May 20, 1978, are occordance with the provisions of the Federal Food, Drug, devices mat have been recuired in assere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, distore, mances 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 If your device is clussified (600 acorre) affecting your device can be found in Title 21, additional controls. Blackly indjes regulation, 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 of any 1 coural statures and enginements, 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 medical device-related adverse events) (21 CF regulation (21 CFR Part 820). This letter requirements as set form in the quality systems (20) regardina (20 constitution of legally market will allow you to begin marketing your device of your device to a legally marketed notification. The FDA finding of subsantal equivalise of the many of the spermits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice for your device on our into Evaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device Frances to premark 5450. Also, please note the regulation entitled, "Misbranding by reference to premating of odverse even 5450. Also, please note the regulation canactions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 CFR Pat 803), pices go to http://www.fda.gov/MedicalDevices/Safety/Reportalers/default.html for the CDRH's Office nttp://www.lda.gov/Nionetrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the You may obtain other geliefal informational and Copymer 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 K072984 510(k) Number (if Known): To be assigned Device Name: Saturn 9000-550 Indications For Use: The Saturn 9000-550 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000-550 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000-550 is intended to be used in same clinical application as traditional film-screen based general radiography system. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CIONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Arst M. Whry etiva. Abdominal a 510(k) Nu Page 1 of 1