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.

AI/ML Overview

Based on the provided text, the device in question (uDR 780i) is a digital medical X-ray system, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate conventional X-ray system, rather than an AI/ML algorithm's performance on a diagnostic task like detecting pathology.

The document is a 510(k) summary for a medical device. For devices like this, the "acceptance criteria" are generally compliance with recognized performance standards and demonstration that the device's technical specifications and intended use are substantially equivalent to a legally marketed predicate device. The "study" largely involves non-clinical bench testing and a review of clinical images by an expert to confirm diagnostic quality.

Here's the breakdown of information based on the typical requirements for an AI/ML medical device, applied to this conventional X-ray system where applicable:

Acceptance Criteria and Device Performance (for a Conventional X-ray System)

The acceptance criteria are not explicitly laid out in a quantifiable table as they would be for an AI diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device (NOVA FA DR System, K133782) regarding intended use, technological characteristics, safety, and effectiveness.

Table 1: Comparison of Technology Characteristics (Relevant for "Performance")

Item	Proposed Device uDR 780i	Predicate Device NOVA FA DR System	Remark (If applicable, implies meeting acceptance through equivalence)
General
Product Code	KPR	KPR	Same
Regulation No.	892.1680	896.1680	Same
Class	II	II	Same
Intended Use	Diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, other anatomic sites for adults and pediatrics. Not for mammography.	Diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, other body parts for adults and pediatrics. Not for mammography.	Same
Specifications (Selected - see full Table 1 for all)
High Voltage Generator
Rated Power/kW	65kW/80kW	50kW/65kW/80kW	Note 1: Does not affect safety/effectiveness as clinical applications achievable under 65kW/80kW.
Max. tube Voltage (kV)	150kV	150kV	Same
Shortest exposure time	1ms	1ms	Same
X-Ray Tube Assemble
Focus Nominal Value	0.6/1.2mm	0.6/1.2mm	Same
Maximum peak voltage	150kV	150kV	Same
Anode Heat Content	300kHU/400kHU	300kHU/400kHU	Same
Anode Target Angle	12°	12°	Same
X-ray tube assembly Heat content	900kJ (1.3MHU) / 1111kJ (1.5MHU)	900kJ (1.3MHU) / 950kJ (1.33MHU)	Note 2: Determines continuous exposure time, but not image quality, thus no impact on safety/effectiveness.
Flat Panel Detector
Configuration	Battery or AC operated	Battery or AC operated	Same
Digital Panels	Amorphous silicon (a-Si)	Amorphous silicon (a-Si)	Same
Scintillator	Cesium iodide (CsI)	Cesium iodide (CsI)	Same
Specifications	3320x3408 125μm	3320x3408 125μm	Same
Effective radiographic size	41.5cm x 42.6cm	41.5cm x 42.6cm	Same
Collimator
Inherent filtration	1mm Al	1mm Al	Same
Copper prefilter	without filter, 0.1 mm, 0.2 mm, 0.3 mm;	without filter, 0.1 mm, 0.2 mm, 0.3 mm;	Same
Display
Specification	24inch, 1200x1920	19inch, 1024 x 1280	Note 3: Larger display is user-friendly, no impact on safety/effectiveness.
DICOM	DICOM3	DICOM3	Same
Patient Table
Motorized vertical travel	38.2cm	40cm	Note 4: Small difference, affects user experience but not clinical application or safety/effectiveness.
X-ray absorption	≤0.8mmAl	≤1mmAl	Note 5: Lower absorption is better, optimizes image quality, no impact on safety/effectiveness.
Max. patient weight	225kg	350kg	Note 7: 225kg sufficient for most patients, no impact on safety/effectiveness.
Software Function (e.g., Image Search, Image Viewing, Image measurement, Image Annotation, Raw image Data processing, Post image data processing)	Yes	Yes	All "Same" functionality
Safety
Electrical Safety	AAMI ANSI ES60601-1; IEC 60601-1	Comply with IEC60601-1	Same
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Same
Biocompatibility	Tested (ISO 10993-5, -10)	Comply with ISO10993-5, ISO10993-10	Same

Study Information (as applicable for a conventional X-ray system submission)

Sample size used for the test set and the data provenance:
- The document states "Sample clinical images accompanied by dose information and information detailing acquisition protocols and parameters were reviewed." It does not specify a numerical sample size for this "test set" of images.
- Data Provenance: Not explicitly stated, but typically for 510(k) submissions of conventional imaging devices, real-world images from a hospital or clinic would be used. The document is from Shanghai United Imaging Healthcare Co., Ltd. in CHINA, implying the images could be from China, but this is not explicitly stated. It's a retrospective review of generated images, not implied as prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- One expert was used: "a board certified radiologist".
- Qualifications: "board certified radiologist with a statement indicating that images are of diagnostic quality." No specific years of experience are mentioned.
Adjudication method for the test set:
- "None" explicitly described for establishing ground truth from multiple readers. There was only one radiologist reviewer for the "clinical images."
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study (MRMC comparing human readers with and without AI assistance) is not applicable or mentioned because the uDR 780i is a conventional X-ray system, not an AI-powered diagnostic assist device. The "effectiveness" is demonstrated through substantial equivalence to a predicate device and diagnostic quality of images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a conventional X-ray system. The "performance" is about image quality for human interpretation, not an algorithm's standalone diagnostic ability. The statement "images are of diagnostic quality" indicates that the images produced by the device, when viewed by a human expert, are sufficient for diagnosis.
The type of ground truth used:
- Expert consensus (from a single board-certified radiologist) on the diagnostic quality of the images generated by the device. It's about image quality, not the presence or absence of specific pathologies based on a gold standard (like pathology or outcomes data).
The sample size for the training set:
- Not applicable. As a conventional X-ray system, there isn't an AI model with a distinct "training set" in the sense of machine learning. The system's "training" refers to its design and engineering adhering to standards and producing high-quality images.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7. The "ground truth" here is the engineering and design principles that ensure the system produces diagnostically acceptable images, confirmed through non-clinical testing and expert review of clinical images.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K173953

Device Name uDR 780i

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

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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.

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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 DeviceuDR 780i	Predicate DeviceNOVA 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 medicalX-ray system is intended foruse by a qualified/traineddoctor or technician on bothadult and pediatric subjects fortaking diagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other anatomicsites. Applications can beperformed with the subjectsitting, standing, or lying in theprone or supine position. Notfor mammography.	Sedecal "NOVA FA DRSystem" is intended for useby qualified/trained doctor ortechnician on both adult andpediatric subjects for takingdiagnostic radiographicexposures of the skull, spinalcolumn, chest, abdomen,extremities, and other bodyparts. Applications can beperformed with the patientsitting, standing, or lying inthe prone or supine position.Not for mammography.	Same
Specifications
High Voltage Generator
RatedPower/kW	65kW/80kW	50kW/65kW/80kW	Note1
Max. tubeVoltage(kV)	150kV	150kV	Same
Shortestexposure time	1ms	1ms	Same
X-Ray Tube Assemble
Focus NominalValue	0.6/1.2mm	0.6/1.2mm	Same
Maximum peakvoltage	150kV	150kV	Same
Anode HeatContent	300kHU/400kHU	300kHU/400kHU	Same
Anode TargetAngle	12°	12°	Same
X-ray tubeassembly Heatcontent	900kJ (1.3MHU)1111kJ (1.5MHU)	900kJ(1.3MHU)950kJ(1.33MHU)	Note2
Flat Panel Detector
Configuration of	Battery or AC operated	Battery or AC operated	Same
Item	Proposed DeviceuDR 780i	Predicate DeviceNOVA FA DR System	Remark
Digital Panels	Semiconductor materialAmorphous silicon (a-Si)	Semiconductor materialAmorphous silicon (a-Si)	Same
ScintillatorCesium iodide(CsI)	Scintillator Cesium iodide(CsI)	Scintillator Cesium iodide(CsI)	Same
specifications	3320x3408 125μm	3320x3408 125μm	Same
Effectiveradiographicsize	41.5cm x 42.6cm	41.5cm x 42.6cm	Same
Collimator
Inherentfiltration	1mm Al	1mm Al	Same
Copper prefilter	without filter,0.1 mm,0.2 mm,0.3 mm;	without filter,0.1 mm,0.2 mm,0.3 mm;	Same
Display
Specification	24inch, 1200x1920	19inch, 1024 x 1280	Note3
Standards
DICOM	DICOM3	DICOM3	Same
Power Source	AC Line, Various voltagesavailable	AC Line, Various voltagesavailable	Same
Patient Table
Motorizedvertical travel	38.2cm	40cm	Note4
X-rayabsorption	≤0.8mmAl	≤1mmAl	Note5
Tabletop travel	Longitudinal: ±40cmTransverse:±12.5cm	Longitudinal:+50cm, -60cmTransverse:±12cm	Note6
Max. patientweight	225kg	350kg	Note7
Detector travelrange	≤67cm	≤60cm	Note8
Auto trackingfor adjusting thetable height ismaintained	Yes, X-ray tube follows tableheight adjustment; source-image distance is maintained.	Yes, X-ray tube follows tableheight adjustment; source-image distance is maintained.	Same
Auto trackingfor longitudinaltube travel	Yes, detector follows tubemovement; centeringmaintained	Yes, detector follows tubemovement; centeringmaintained	Same
Item	Proposed DeviceuDR 780i	Predicate DeviceNOVA FA DR System	Remark
Auto trackingfor tube rotation	Yes, detector follows tubemovement; centeringmaintained.	Yes, detector follows tubemovement; centeringmaintained.	Same
Softwarefunction
Import/Exportimages	Yes	Yes	Same
Image Searchavailable	Yes	Yes	Same
Image Viewing	Yes	Yes	Same
Imagemeasurement	Yes	Yes	Same
ImageAnnotation	Yes	Yes	Same
ImageOperations	Yes	Yes	Same
Generator	Yes	Yes	Same
Raw image Dataprocessing	Yes	Yes	Same
Post image dataprocessing	Yes	Yes	Same
Safety
Electrical Safety	AAMI ANSI ES60601-1:C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) Medicalelectrical equipment - Part 1:General requirements for basicsafety and essentialperformance (IEC 60601-1:2005, MOD)	Comply with IEC60601-1	Same
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Same
Biocompatibility	Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10).	Comply with ISO10993-5,ISO10993-10	Same
Justification
Note ID	Justification
Note 1	The proposed device does not have rated power of 50kW compare withthe predicate device. However, the all clinical application can be achievedunder 65kW and 80kW, which the predicate device also has. Therefore,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.

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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.

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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.

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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.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.