uDR 780i

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG" and "ADMINISTRATION". November 1, 2024 Shanghai United Imaging Healthcare Co., Ltd. % Gao Xin Regulatory Affairs Manager No.2258 Chengbei Rd. Jiading District Shanghai, 201807 CHINA Re: K241068 Trade/Device Name: uDR 780i Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: July 8, 2024 Received: September 30, 2024 Dear Gao Xin: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241068 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 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) | | |--------------------------------------------------|---------------------------------------------| | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### 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." {4}------------------------------------------------ ## K241068 Image /page/4/Picture/2 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. The logo is simple and modern in design. ## 510 (k) SUMMARY - Date of Preparation: 1. July 5, 2024 - 2. Sponsor Identification Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Establishment Registration Number: 3011015597 Contact Person: Xin Gao Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com #### Identification of Proposed Device 3. 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 - 4. Identification of Predicate Device(s) Predicate Device 510(k) Number: K173953 Device Name: Stationary X-Ray System ## Regulatory Information Classification Name: Stationary X-Ray System Classification: II Product Code: KPR Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology {5}------------------------------------------------ Shanghai United Imaging Healthcare Co., Ltd. Tel: +86 (21) 67076888 Fax: +86 (21) 67076889 www.united-imaging.com Image /page/5/Picture/2 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 text is a stylized "U" shape, formed by two vertical lines connected by a curved base. The logo is presented in a dark gray color. #### 5. 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. #### Intended Use Statement: 6. The uDR780i 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. #### Substantially Equivalent (SE) Comparison 7. A comparison between the technological characteristics of proposed and predicate devices is provided as below. | | Proposed Device | Predicate Device | Remark | |---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Item | uDR 780i | uDR 780i<br>K173953 | | | General | | | | | Product Code | KPR | KPR | Same | | Regulation No. | 892.1680 | 896.1680 | Same | | Class | II | II | Same | | Intended Use | 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. | 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. | Same | | Specifications | | | | | High Voltage Generator | | | | | | Proposed Device | Predicate Device | Remark | | Item | uDR 780i | uDR 780i<br>K173953 | | | Max. Power/kW | 65kW/80kW | 65kW/80kW | Same | | Max. tube<br>Voltage(kV) | 150kV | 150kV | Same | | Shortest exposure<br>time | 1ms | 1 ms | Same | | X-Ray Tube Assemble | | | | | Focus Nominal<br>Value | 0.6/1.2 | 0.6/1.2 | Same | | Maximum peak<br>voltage | 150kV | 150kV | Same | | Anode Heat<br>Content | 65kw: ≥300kHU<br>80kw: ≥400kHU | 65kw: ≥300kHU<br>80kw:≥400kHU | Same | | Anode Target<br>Angle | 12° | 12° | Same | | X-ray tube<br>assembly Heat<br>content | 65kw: ≥1250KHU<br>80kw: ≥1500KHU | 65kw: ≥1250KHU<br>80kw: ≥1500KHU | Same | | Flat Panel<br>Detector | | | | | Configuration<br>of Digital Panels | Battery or DC operated | Battery or AC operated | Note1 | | Semiconductor<br>material<br>Amorphous silicon<br>(a-Si) | Semiconductor material Amorphous<br>silicon (a-Si) | Semiconductor<br>material<br>Amorphous silicon (a-Si) | Same | | Scintillator Cesium<br>iodide (CsI) | Scintillator Cesium iodide (CsI) | Scintillator Cesium iodide (CsI) | Same | | specifications | 3320x3408<br>125µm | 3320x3408<br>125µm | Same | | Effective<br>radiographic size | 41.5cm x 42.6cm | 41.5cm x 42.6cm | Same | | Collimator | | | | | Inherent filtration | 1mm Al | 1mm Al | Same | | | 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 | | Copper prefilter | | | | | Display | | | | | Specification | ≥21inch, ≥ 1080x1920 | 24inch, 1200x1920 | Note2 | | Standards | | | | | DICOM | DICOM3 | DICOM3 | Same | | Power Source | AC Line, Various voltages available | AC Line, Various voltages | Same | | Item | Proposed Device<br>uDR 780i | Predicate Device<br>uDR 780i<br>K173953<br>available | Remark | | Patient Table | | | | | Motorized vertical<br>travel | $\geq$ 38.2cm | $\geq$ 38.2cm | Same | | X-ray absorption | < 0.8mmAl | < 0.8mmAl | Same | | Tabletop travel | Longitudinal: $\geq$ 800mm<br>Transverse: $\geq$ 250mm | Longitudinal: $\pm$ 40cm<br>Transverse: $\pm$ 12.5cm | Note3 | | Max. patient<br>weight | 320kg | 225kg | Note4 | | Detector travel<br>range | $\geq$ 67cm | $\leq$ 67cm | Note5 | | Auto tracking for<br>adjusting the table<br>height is<br>maintained | Yes, X-ray tube follows table height<br>adjustment; source-image distance<br>is maintained. | Yes, X-ray tube follows table<br>height adjustment; source-image<br>distance is maintained. | Same | | Auto tracking for<br>longitudinal tube<br>travel | Yes, detector follows tube<br>movement; centering maintained. | Yes, detector follows tube<br>movement; centering maintained. | Same | | Auto tracking for<br>tube rotation | Yes, detector follows tube<br>movement; centering maintained. | Yes, detector follows tube<br>movement; centering maintained. | Same | | Software 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 Annotation | Yes | Yes | Same | | Image 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 | ANSI/AAMI ES 60601-1:2005 &<br>A1:2012 & A2:2021 Medical<br>electrical equipment - Part 1:<br>General requirements for basic | AAMI ANSI ES60601-<br>1:C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text) Medical electrical equipment | Note6 | | Item | Proposed Device<br>uDR 780i | Predicate Device<br>uDR 780i<br>K173953 | Remark | | | safety and essential performance | - Part 1:<br>General requirements for basic<br>safety and essential performance<br>(IEC 60601-1:2005, MOD) | | | 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). | 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).<br>Comply with ISO10993-5,<br>ISO10993-10 | Same | | Clinical | Clinical Image Evaluation for the proposed device are provided in Section 28 Clinical<br>Image Evaluation. | | | | Justification | | | | | Note ID | Justification | | | | Note 1 | 1. The configuration of Digital Panel Detector of predicate device is<br>power by Battery or operate in DC power, but there was an error in the<br>description in the previous submission of K173953;<br>2. The configuration of Digital Panel Detector of the proposed device<br>and predicate device is the same, which is power by Battery or operate<br>in DC power. | | | | Note 2 | Compare the predicted device, the proposed device has added multiple display options<br>through design changes, and these display specification all meet the requirements. | | | | Note 3 | Compare the predicted device, the proposed device design has not been changed, and<br>a clearer definition of Tabletop travel has been provided to meet the production<br>requirements. | | | | Note 4 | Compare the predicted device, the proposed device has increased the max. patient<br>weight of the Patient Table by design change, make patient table to have better<br>performance. | | | | Note 5 | Compare the predicted device, the proposed device design has not been changed,<br>corrected description error in the predict device. | | | | Note 6 | The proposed device meets the requirement of the latest ANSI/AAMI ES 60601-1<br>standard. | | | Table 1 Comparison of Technology Characteristics {6}------------------------------------------------ Shanghai United Imaging Healthcare Co., Ltd. Tel: +86 (21) 67076888 Image /page/6/Picture/2 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 emblem that resembles a shield or a stylized letter U. The emblem is a solid color, and it has a vertical line running down the center, with a horizontal line connecting to it at the top. {7}------------------------------------------------ Shanghai United Imaging Healthcare Co., Ltd. Fax: +86 (21) 67076889 Tel: +86 (21) 67076888 www.united-imaging.com Image /page/7/Picture/2 description: The image shows 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" symbol, which is dark teal in color. The logo is simple and modern. {8}------------------------------------------------ # K241068 Shanghai United Imaging Healthcare Co., Ltd. Tel: +86 (21) 67076888 Image /page/8/Picture/2 description: The image shows 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 words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted. {9}------------------------------------------------ Image /page/9/Picture/2 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 text is a stylized "U" shape, which is dark gray with a white line running vertically through the center, creating a visual effect of two vertical bars within the "U" shape. The overall design is clean and modern. #### Non-Clinical Test Conclusion 8. 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: - A ANSI/AAMI ES 60601-1:2005 & A1:2012 & A2:2021 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance. - > IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. - > IEC 60601-1-3:2008+A1:2013+A2:2021 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment. - > IEC 60601-2-54:2022 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. - > IEC 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis #### 9. Clinical Image Evaluation The clinical image evaluation was performed under the proposed device. Sample images of chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission. Each image was reviewed with a statement indicating that image quality is sufficient for clinical diagnosis. ### 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the technology characteristics of the modified uDR 780i, reflected in this 510(k) submission, do not alter the scientific technology of the devices and are substantially equivalent to those of the predicate devices. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. we conclude that the modified uDR 780i Stationary X-Ray Systems are substantially equivalent to the predicate devices. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.