uDR 592h, uDR 596i

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Shanghai United Imaging Healthcare Co., Ltd. Jiading District % Xin Gao Regulatory Affairs Specialist No. 2258 Chengbei Road Shanghai, Shanghai, 201807 CHINA ### Re: K192293 Trade/Device Name: uDR 592h, uDR 596i Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB, KPR Dated: August 20, 2019 Received: August 23, 2019 #### 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. 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 located 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. 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 September 12, 2019 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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-regulatoryassistance/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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192293 Device Name uDR 592h, uDR 596i Indications for Use (Describe) The uDR 592h, uDR596i Radiographic system is intended to 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, limbs and trunk .Not for mammography. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 12px;">☐</span> 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." {3}------------------------------------------------ Image /page/3/Picture/1 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 letter "U" that is dark gray. The logo is simple and modern. ## 510 (k) SUMMARY ### K192293 - 1. Date of Prepared August 20, 2019 ### 2. Sponsor Identification Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China Contact Person: Xin GAO Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com ### 3. Identification of Proposed Device(s) Trade Name: uDR 592h, uDR 596i Common Name: Digital Medical X-ray System Model(s): uDR 592h, uDR 596i Regulatory Information Classification Name: Stationary X-Ray System Classification: II Product Code: KPR, MQB Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology ### 4. Identification of Predicate Device(s) 510(k) Number: K181413 Device Name: uDR 592h, uDR 596i Manufacturer: Shanghai United Imaging Healthcare Co.,Ltd. #### Regulatory Information Classification Name: Stationary X-Ray System Classification: II Product Code: KPR, MQB Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a 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, and the use of bold text and a geometric shape makes it easily recognizable. ## 5. Device Description The uDR 592h, uDR 596i is a digital medical X-ray imaging system that the X-ray generated by the X-ray tube assembly is converted into digital signal through flat panel detector, finally image data using TCP/IP protocol transfers to image process software. The software mainly has the following functions: - A Patient Administration: supporting RIS and PACS system, register the emergency patient, dynamic real-time patient information search and display, support the display and ranking of examinations in different statuses; - A Acquisition and post processing: selecting radiography protocol, display and adjust the exposure parameter, image acquisition and image display, provide image processing tools, such as zoom, pan, adjust window width/window level, delete all graphics, annotation and text, rotate, flip, gray invert, pixel lens, ROI zoom, cut, reload and reset; - Image Transmission and Filming Function: image transmission to PACS server, A filming layout, filming preview, life-size filming, DVD burning function, image export and import function, supporting the USB device. The uDR 592h, uDR 596i have been previously cleared by FDA via K181413. The modifications performed on the uDR 592h, uDR 596i (K181413) in this submission are due to the addition of an 80kW high voltage generator, x-ray tube and a new grid configuration (130 cm). Meanwhile, patient table and stitching stand have been optimized. The modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are following: - A Introduce a 80kW high voltage generator and X-ray tube - Introduce a new grid configuration (focus: 130cm, grid line: 40L/cm, ratio: A 8:1) - A Increase the maximum load weight of patient table and stitching stand. This proposed device includes two models: uDR 592h, uDR 596i.The differences between the two models are as follows: | Spec.<br>Model | HVG Power | Maximum Tube<br>Current | Remark | |----------------|-----------|-------------------------|-------------------------------------------------| | uDR 596i | 80kW | 1000 mA | New configuration in this<br>submission | | uDR 596i | 65kW | 800 mA | Configuration in previous<br>submission K181413 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is formed by two vertical lines connected by a horizontal line at the top, with a semi-circle at the bottom. | | 80kW | 1000 mA | New configuration in this submission | |----------|------|---------|-------------------------------------------------| | uDR 592h | 65kW | 800 mA | Configuration in previous<br>submission K181413 | | | 50kW | 630 mA | Configuration in previous<br>submission K181413 | ## 6. Indications for Use The uDR 592h, uDR 596i Radiographic system is intended to 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, limbs and trunk. Not for mammography. ### 7. Technological Characteristic The technology characteristics of the modified uDR 592h and uDR 596i, 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. Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device. | Table 1 Comparison of Technological Characteristics | | | | |-----------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------|--------| | ITEM | Predicate Device<br>uDR 592h, uDR 596i<br>(K181413) | Proposed Device<br>uDR 592h, uDR 596i | Remark | | Specifications | | | | | High Voltage Generator | | | | | Rated Power | uDR 592h: 50kW, 65kW<br>uDR 596i: 65kW | uDR592h: 50kW, 65kW, 80kW<br>uDR596i: 65kW, 80kW | Note 1 | | Max. tube Voltage | 150kV | 150kV | Same | | Shortest exposure time | 1ms | 1ms | Same | | X-Ray Tube Assemble | | | | | Focus Nominal Value | 0.6mm, 1.2mm | 0.6mm, 1.2mm | Same | | Maximum peak voltage | 150kV | 150kV | Same | | Anode Heat Content | uDR 592h: 230kHU, 300kHU<br>uDR 596i: 300kHU | uDR 592h: 230kHU, 300kHU, 400kHU<br>uDR 596i: 300kHU, 400kHU | Note 2 | | Anode Target Angle | 12° | 12° | Same | | X-ray tube assembly<br>Heat content | uDR592h: 1.354 MHU /1.25 MHU | uDR592h: 1.354 MHU /1.25 MHU/1.5 MHU | Note 3 | | ITEM | Predicate Device<br>uDR 592h, uDR 596i<br>(K181413) | Proposed Device<br>uDR 592h, uDR 596i | Remark | | | uDR596i: 1.25MHU | uDR596i: 1.25 MHU/1.5<br>MHU | | | Collimator | | | | | Inherent filtration | 1mm Al | 1mm Al | Same | | | without filter, | without filter, | | | Copper prefilter | 0.1 mm, | 0.1 mm, | Same | | | 0.2 mm | 0.2 mm | | | Flat Panel Detector | | | | | Flat Panel Detector | Mars1717XU-VSI | Mars1717XU-VSI | Same | | Display | | | | | Size and Resolution | 24inch, 1200x1920 | 24inch, 1200x1920 | Same | | Standards | | | | | DICOM | DICOM3 | DICOM3 | Same | | Power Source | AC Line, Various | AC Line, Various voltages | Same | | | voltages available | available | | | Patient Table | | | | | Table height | 68cm | 68cm | Same | | X-ray absorption | ≤0.7mmAl | ≤0.7mmAl | Same | | | Longitudinal: ±50cm | Longitudinal: ±50cm | Same | | Tabletop travel | Transverse: ±12cm | Transverse: ±12cm | | | Max. patient weight | 200kg | 250kg | Note 4 | | Detector travel range | ≥50cm | ≥50cm | Same | | Software functions | | | | | Import/Export images | Yes | Yes | Same | | Image Viewing | Yes | Yes | Same | | Image Annotation | Yes | Yes | Same | | Patient and study | Yes | Yes | Same | | administration | | | | | Store/delete/Recover | Yes | Yes | Same | | rejected images | | | | | Exposure Index | Yes | Yes | Same | | monitoring | | | | | Image documentation | Yes | Yes | Same | | and achieving | | | | | Automatic exposure | Yes | Yes | Same | | control | | | | | stitching | Only yes for uDR596i | Only yes for uDR596i | Same | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, dark blue letters, stacked on top of each other. To the right of the text is a stylized, dark blue symbol that resembles a shield with a vertical white line running down the center, creating a split effect. The overall design is clean and modern. ## Justification {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of two parts: the text "UNITED IMAGING" in bold, sans-serif font, and a stylized "U" symbol to the right. The "U" symbol is a dark teal color and has a white vertical line running through the center, creating a unique design. The text and symbol are aligned horizontally. | Note ID | Justification | |---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Note 1 | The proposed device provides an additional generator configuration with rated power of 80kW compare with the predicate device. The new generator configuration with rated power of 80kW have the same clinical application with the generators in the predicated device, but it can cover more patients with bigger body size than predicated device. This difference does not affect safety and effectiveness in digital radiography. | | Note 2 | Compare with the predicate devices, the proposed devices provide an additional tube with anode heat content of 400kHU, which are used to cooperate with the generator configuration of 80KW. This difference does not change the clinical application and does not affect safety and effectiveness in digital radiography. | | Note 3 | The additional tube has different X-ray tube assembly Heat content compare with predicated devices, which does not change the clinical application and does not affect safety and effectiveness in digital radiography. | | Note 4 | The patient table has bigger Max. Patient weight in proposed devices than the predicated devices. It can cover more patients with bigger body size than predicated device. This difference does not affect safety and effectiveness in digital radiography. | ## 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. ## Non-Clinical Testing The following testing was conducted on the proposed devices: - Performance test for uDR 596i (80KW) and uDR 592h (80KW) A - > ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - A IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance - > IEC 60601-1-3 Medical electrical equipment Part 1-3: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment - > IEC 60601-2-54 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, dark blue font. To the right of the words is a stylized "U" symbol, also in dark blue, with a vertical line running through the center of the "U". ## Software - NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM) - A IEC 62304: Medical Device Software - software life cycle process - > Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - > Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ### Software Verification and Validation As a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'', the risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence. UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. ## Clinical Testing No clinical testing was conducted on the proposed devices. ## 9. Conclusion 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 592h and uDR 596i 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.