uDR 780i

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font. Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Rd., Jiading Industrial District Shanghai. 201807 CHINA January 26, 2018 # Re: K173953 Trade/Device Name: uDR 780i Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 25, 2017 Received: December 27, 2017 Dear Xin GAO: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D.'Hara For Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173953 Device Name uDR 780i #### Indications for Use (Describe) The uDR 780i digital medical x-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography. Type of Use (Select one or both, as applicable) | <div> <span style="font-size:10pt">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |--------------------------------------------------------------------------------------------------------| | <div> <span style="font-size:10pt">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized "U" shape, also in a bold, sans-serif font, with a horizontal line running through the middle of the "U". # 510 (k) SUMMARY - 1. Date of Preparation: December 25, 2017 #### 2. Sponsor Identification Shanghai United Imaging Healthcare Co..Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Establishment Registration Number: Not yet registered or the Number Contact Person: Xin Gao Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com #### 3. Identification of Proposed Device Trade Name: uDR 780i Common Name: Digital Medical X-ray System Model(s): uDR 780i # Regulatory Information Classification Name: Stationary X-Ray System Classification: II Product Code: KPR Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology ### Intended Use Statement: The uDR 780i digital medical X-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography. ### Device Description: The uDR 780i is a digital radiography (DR) system that is designed to provide radiography examinations of sitting, standing or lying patients. It consists of the following components: Tube Ceiling Suspension with tube and collimator, Bucky Wall Stand, Elevating Table, High Voltage Generator, wireless flat panel detectors and an acquisition workstation. The system generates images which can be transferred through DICOM network for printing, review and storage. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a dark color. The logo appears to be clean and modern in design. #### Identification of Predicate Device(s) 4. ### Predicate Device 510(k) Number: K133782 Device Name: NOVA FA DR System Regulatory Information Classification Name: Stationary X-Ray System Classification: II Product Code: KPR Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology #### 5. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - > ES60601-1:2005(R)2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. - > IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. - > IEC 60601-1-3 Edition 2.1 2013-04. Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment. - A IEC 60601-2-54 Edition1.1 2015-04 Medical electrical equipment-Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. - > IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment -Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis #### 6. Clinical Test Conclusion Sample clinical images accompanied by dose information and information detailing acquisition protocols and parameters were reviewed by a board certified radiologist with a statement indicating that images are of diagnostic quality. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is also in a bold, sans-serif font and is colored in a dark teal. # 7. Substantially Equivalent (SE) Comparison Table 1 Comparison of Technology Characteristics | Item | Proposed Device<br>uDR 780i | Predicate Device<br>NOVA FA DR System | Remark | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | General | | | | | Product Code | KPR | KPR | Same | | Regulation No. | 892.1680 | 896.1680 | Same | | Class | II | II | Same | | Intended Use | The uDR 780i digital medical<br>X-ray system is intended for<br>use by a qualified/trained<br>doctor or technician on both<br>adult and pediatric subjects for<br>taking diagnostic radiographic<br>exposures of the skull, spinal<br>column, chest, abdomen,<br>extremities, and other anatomic<br>sites. Applications can be<br>performed with the subject<br>sitting, standing, or lying in the<br>prone or supine position. Not<br>for mammography. | Sedecal "NOVA FA DR<br>System" is intended for use<br>by qualified/trained doctor or<br>technician on both adult and<br>pediatric subjects for taking<br>diagnostic radiographic<br>exposures of the skull, spinal<br>column, chest, abdomen,<br>extremities, and other body<br>parts. Applications can be<br>performed with the patient<br>sitting, standing, or lying in<br>the prone or supine position.<br>Not for mammography. | Same | | Specifications | | | | | High Voltage Generator | | | | | Rated<br>Power/kW | 65kW/80kW | 50kW/65kW/80kW | Note1 | | Max. tube<br>Voltage(kV) | 150kV | 150kV | Same | | Shortest<br>exposure time | 1ms | 1ms | Same | | X-Ray Tube Assemble | | | | | Focus Nominal<br>Value | 0.6/1.2mm | 0.6/1.2mm | Same | | Maximum peak<br>voltage | 150kV | 150kV | Same | | Anode Heat<br>Content | 300kHU/400kHU | 300kHU/400kHU | Same | | Anode Target<br>Angle | 12° | 12° | Same | | X-ray tube<br>assembly Heat<br>content | 900kJ (1.3MHU)<br>1111kJ (1.5MHU) | 900kJ(1.3MHU)<br>950kJ(1.33MHU) | Note2 | | Flat Panel Detector | | | | | Configuration of | Battery or AC operated | Battery or AC operated | Same | | Item | Proposed Device<br>uDR 780i | Predicate Device<br>NOVA FA DR System | Remark | | Digital Panels | Semiconductor material<br>Amorphous silicon (a-Si) | Semiconductor material<br>Amorphous silicon (a-Si) | Same | | Scintillator<br>Cesium iodide<br>(CsI) | Scintillator Cesium iodide<br>(CsI) | Scintillator Cesium iodide<br>(CsI) | Same | | specifications | 3320x3408 125μm | 3320x3408 125μm | Same | | Effective<br>radiographic<br>size | 41.5cm x 42.6cm | 41.5cm x 42.6cm | Same | | Collimator | | | | | Inherent<br>filtration | 1mm Al | 1mm Al | Same | | Copper prefilter | without filter,<br>0.1 mm,<br>0.2 mm,<br>0.3 mm; | without filter,<br>0.1 mm,<br>0.2 mm,<br>0.3 mm; | Same | | Display | | | | | Specification | 24inch, 1200x1920 | 19inch, 1024 x 1280 | Note3 | | Standards | | | | | DICOM | DICOM3 | DICOM3 | Same | | Power Source | AC Line, Various voltages<br>available | AC Line, Various voltages<br>available | Same | | Patient Table | | | | | Motorized<br>vertical travel | 38.2cm | 40cm | Note4 | | X-ray<br>absorption | ≤0.8mmAl | ≤1mmAl | Note5 | | Tabletop travel | Longitudinal: ±40cm<br>Transverse:±12.5cm | Longitudinal:+50cm, -60cm<br>Transverse:±12cm | Note6 | | Max. patient<br>weight | 225kg | 350kg | Note7 | | Detector travel<br>range | ≤67cm | ≤60cm | Note8 | | Auto tracking<br>for adjusting the<br>table height is<br>maintained | Yes, X-ray tube follows table<br>height adjustment; source-<br>image distance is maintained. | Yes, X-ray tube follows table<br>height adjustment; source-<br>image distance is maintained. | Same | | Auto tracking<br>for longitudinal<br>tube travel | Yes, detector follows tube<br>movement; centering<br>maintained | Yes, detector follows tube<br>movement; centering<br>maintained | Same | | Item | Proposed Device<br>uDR 780i | Predicate Device<br>NOVA FA DR System | Remark | | Auto tracking<br>for tube rotation | Yes, detector follows tube<br>movement; centering<br>maintained. | Yes, detector follows tube<br>movement; centering<br>maintained. | Same | | Software<br>function | | | | | Import/Export<br>images | Yes | Yes | Same | | Image Search<br>available | Yes | Yes | Same | | Image Viewing | Yes | Yes | Same | | Image<br>measurement | Yes | Yes | Same | | Image<br>Annotation | Yes | Yes | Same | | Image<br>Operations | Yes | Yes | Same | | Generator | Yes | Yes | Same | | Raw image Data<br>processing | Yes | Yes | Same | | Post image data<br>processing | Yes | Yes | Same | | Safety | | | | | Electrical Safety | AAMI ANSI ES60601-<br>1:C1:2009/(R)2012 and<br>A2:2010/(R)2012<br>(Consolidated Text) Medical<br>electrical equipment - Part 1:<br>General requirements for basic<br>safety and essential<br>performance (IEC 60601-<br>1:2005, MOD) | Comply with IEC60601-1 | Same | | EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same | | Biocompatibility | Patient Contact Materials were<br>tested and demonstrated no<br>cytotoxicity (ISO 10993-5), no<br>evidence for irritation and<br>sensitization (ISO 10993-10). | Comply with ISO10993-5,<br>ISO10993-10 | Same | | Justification | | | | | Note ID | Justification | | | | Note 1 | The proposed device does not have rated power of 50kW compare with<br>the predicate device. However, the all clinical application can be achieved<br>under 65kW and 80kW, which the predicate device also has. Therefore,<br>this difference does not affect safety and effectiveness in digital | | | | Item | Proposed Device | Predicate Device | Remark | | | uDR 780i | NOVA FA DR System | | | | radiography. | | | | Note 2 | The heat content of tube assembly determines the continuous exposure time but not affect the image quality, which does not affect safety and effectiveness in digital radiography. | | | | Note 3 | The display with big size is user friendly for the users, which does not affect the safety and effectiveness in digital radiography. | | | | Note 4 | The small difference in table height affects the user experience but not the clinical application. So it is not affect safety and effectiveness. | | | | Note 5 | The x-ray absorption of the table top should as small as possible, it will optimize the image quality. So it is not affect safety and effectiveness. | | | | Note6 | The top travel range affect the user experience but not the clinical application, and the travel range of uDR 780i is enough for the radiography on adults. So it is not affect safety and effectiveness. | | | | Note7 | The Max. Patient weight (225kg) is enough to satisfy the radiography in most patients, which is not affect the safety and effectiveness. | | | | Note8 | The detector travel range affect the user experience, the grater the range the better user experience, which is not affect safety and effectiveness. | | | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is stacked on top of each other and is in a bold, sans-serif font. To the right of the text is a stylized "U" shape that is divided into three sections. The logo is in a dark teal color. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font and is a dark teal color. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the use of a bold font gives it a strong and confident look. ## Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.