uDR 592h, uDR 596i

K181413 · Shanghai United Imaging Healthcare Co., Ltd. · KPR · Jun 27, 2018 · Radiology

Device Facts

• Record ID: K181413
• Device Name: uDR 592h, uDR 596i
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: KPR · Radiology
• Decision Date: Jun 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Digital medical X-ray system; generates X-rays via tube assembly; captures images using flat panel detector; transfers data via TCP/IP to image processing software. System components: Bucky wall stand, tube stand, table, high-voltage generator, collimator, power unit, control console, grid, ionization chamber, stitching stand (uDR 596i only), monitor. Operated by qualified doctors/technicians in clinical settings. Software manages patient administration, image acquisition, post-processing, viewing, annotation, storage, and automatic exposure control (AEC). Stitching function combines 2-4 frames into one. Output used by clinicians for diagnostic assessment of anatomy. Benefits include efficient radiographic imaging and workflow management.

Clinical Evidence

No clinical study included. Substantial equivalence supported by non-clinical bench testing, including dosimetry, image performance, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and software verification/validation. Clinical images for the stitching feature were reviewed by a board-certified radiologist to confirm diagnostic quality.

Technological Characteristics

Stationary digital X-ray system. Components: High-voltage generator (50-65kW), X-ray tube (150kV max), flat panel detector (CsI scintillator, 139µm pixel pitch), collimator. Connectivity: DICOM 3.0, TCP/IP. Software: Moderate level of concern, includes AEC and stitching. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 60601-2-28, IEC 60825-1, ISO 10993-5/10.

Indications for Use

Indicated for adult and pediatric patients requiring diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs, and trunk. Not for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Multix Select DR (K132934)

Reference Devices

• DIGITAL RADIOGRAPHY CXDI-401C Wireless (K133693)

Submission Summary (Full Text)

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June 27, 2018

Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang Om&ra VP No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, 201807 CHINA

Re: K181413

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: KPR, MQB Dated: May 25, 2018 Received: May 30, 2018

Dear Shumei Wang:

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. Iisting 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice

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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.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hole 2. Nils

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) K181413

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*)

| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/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 letter "U" that is dark blue. The logo is simple and modern.

# 510 (k) SUMMARY

- Date of Preparation 1. June 22, 2018
#### 2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Contact Person: Shumei Wang Position: QM&RA VP Tel: [phone]-6776 Fax: [phone] Email: [e-mail]

#### 3. Identification of Proposed Device

510(k) Number: K181413 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)

### Predicate Device

510(k) Number: K132934 Device Name: Multix Select DR Manufacturer: SIEMENS

### Regulatory Information

Classification Name: Stationary X-Ray System Classification: II Product Code: KPR Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology

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Image /page/4/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 a dark gray color.

### Reference Device

510(k) Number: K133693 Device Name: DIGITAL RADIOGRAPHY CXDI-401C Wireless Manufacturer: Cannon.Inc.

Regulatory Information Classification Name: Stationary X-Ray System Classification: II Product Code: MQB Regulation Number: 21 CFR 892. 1680 Review Panel: Radiology

#### 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 system consists of Bucky Wall Stand, Tube Stand, Table, High-voltage Generator, X-ray Tube Assembly, Collimator, Flat Panel Detector, Power Distribute Unit, Control Console, Pluggable Grid, Ionization Chamber, Stitching Stand, Image Processing System and Monitor. The system software is a program used for patient administration, acquisition and post processing, image transmission and filming.

The system software provides functions such as import/export images, image viewing, image annotation, patient and study administration, store/delete/rec-over rejected images, exposure index monitoring, image documentation and achieving, automatic exposure control (AEC), stitching.

For automatic exposure control function, high voltage generator can terminate exposure automatically and the stitching provided in uDR 596i can stitch 2-4 single frame images into a full image.

| Spec.<br>Model | HVG Power | Maximum X-Ray Tube<br>Assembly Heat Content | Maximum Tube Current |
|----------------|--------------|---------------------------------------------|----------------------|
| | | | |
| uDR 592h | 65kW<br>50kW | 900kJ (1.25MHU)<br>975KJ (1354kHU ) | 800 mA<br>630mA |

This proposed device includes two models: uDR 592h, uDR 596i. The differences between the two models are as follows:

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which appears to be a graphical element representing the company. The logo is simple and modern in design.

#### Indications for Use 6.

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.

#### Comparison of Technological Characteristics with the Predicate Devices 7.

The uDR 592h, uDR 596i digital medical X-ray imaging system has the same indications for use as the predicate device Multix Select DR. The fundamental scientific technology of the proposed device is same as the predicate device.

Table 1 below provides a comparison of the technological characteristics and software functions of the proposed device in comparison to the predicate device.

| ITEM | Predicate Device<br>Multix Select DR<br>(K132934) | Proposed Device<br>uDR 592h, uDR 596i<br>(K181413) | Remark |
|-------------------------------------|---------------------------------------------------|------------------------------------------------------------|--------|
| Specifications | | | |
| High Voltage Generator | | | |
| Rated Power/kW | 55kW | 50kW for uDR 592h<br>65kW for uDR 592h and<br>uDR 596i | Note 1 |
| Max. tube Voltage(kV) | 133kV | 150kV | Note 2 |
| 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 | 133kV | 150kV | Note 3 |
| Anode Heat Content | 230kHU | 230kHU for uDR 592h<br>300kHU for uDR 592h<br>and uDR 596i | Note 4 |
| Anode Target Angle | 12° | 12° | Same |
| X-ray tube assembly<br>Heat content | 2240kJ(3MHU) | 900k (1.3MHU) | Note 5 |
| Collimator | | | |
| Inherent 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, | Note 6 |
| Display | | | |
| Size and Resolution | 19inch, 1024 x 1280 | 24inch, 1200x1920 | Note 7 |
| Standards | | | |

of Tochnological Characto Table 1 Comparison c

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Image /page/6/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 "U" shape, which is dark blue and has a white vertical line running through the center.

| ITEM | Predicate Device<br>Multix Select DR<br>(K132934) | Proposed Device<br>uDR 592h, uDR 596i<br>(K181413) | Remark |
|------------------------------------------|---------------------------------------------------|----------------------------------------------------|--------------------------|
| DICOM | DICOM3 | DICOM3 | Same |
| Power Source | AC Line, Various<br>voltages available | AC Line, Various<br>voltages available | Same |
| Table height | 75cm | 68cm | Note 8 |
| X-ray absorption | $\leq1.2mmAl$ | $\leq0.7mmAl$ | Note 9 |
| Tabletop travel | Longitudinal: ± 46cm<br>Transverse: ±12.5cm | Longitudinal: ± 50cm<br>Transverse: ±12cm | Note 10 |
| Max. patient weight | 200kg | 200kg | Same |
| Detector travel range | $\geq57.5cm$ | $\geq50cm$ | Note11 |
| Software functions | | | |
| Import/Export images | Yes | Yes | Functional<br>Equivalent |
| Image Viewing | Yes | Yes | Functional<br>Equivalent |
| Image Annotation | Yes | Yes | Functional<br>Equivalent |
| Patient and study<br>administration | Yes | Yes | Functional<br>Equivalent |
| Store/delete/Rec-over<br>rejected images | Yes | Yes | Functional<br>Equivalent |
| Exposure Index<br>monitoring | Yes | Yes | Functional<br>Equivalent |
| Image documentation<br>and achieving | Yes | Yes | Functional<br>Equivalent |
| Automatic exposure<br>control | Yes | Yes | Functional<br>Equivalent |
| Stitching | No | Only Yes for uDR 596i | Note 12 |

| Justification | |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note ID | Justification |
| Note 1 | The generator (50kW) can satisfy the needs of radiation dose in clinical application. The generator (55kW) can be replaced with generator (65kW) in clinical application, which is not affect safety and effectiveness. |
| Note 2 | Max. tube Voltage determines the highest X-ray quality, which does not affect safety and effectiveness in digital radiography. |
| Note 3 | The peak voltage (133/150kV) can satisfy the standards IEC 60613. |
| Note 4 | The heat content of anode determines the continuous exposure time but not affect the image quality, which does not affect safety and effectiveness in digital radiography. |
| Note 5 | The heat content of tube assembly determines the continuous exposure time but |

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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" shape, which is also in a bold font. The color of the logo is a dark gray.

| | not affect the image quality, which does not affect safety and effectiveness in<br>digital radiography. |
|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 6 | The filter (0.1mm 0.2mm Al) is enough to satisfy the radiography in most<br>clinical application, which does not affect the safety and effectiveness. |
| Note 7 | The display with big size is user friendly for the users, which does not affect the<br>safety and effectiveness in digital radiography. |
| Note 8 | The small difference in table height affects the user experience but not the<br>clinical application. So it does not affect safety and effectiveness. |
| Note 9 | The x-ray absorption of the table top should as small as possible; it will optimize<br>the image quality. So it does not affect safety and effectiveness. |
| Note 10 | The top travel range affect the user experience but not the clinical application,<br>and the travel range of uDR 592h/uDR 596i is enough for the radiography on<br>adults. So it does not affect safety and effectiveness. |
| Note11 | The detector travel range affect the user experience, the grater the range the<br>better user experience, which does not affect safety and effectiveness. |
| Note 12 | This function has been covered by software requirement specifications, and the<br>testing results show that the function has met the acceptance criteria. The<br>clinical images of stitching feature have been reviewed by a board-certified<br>radiologist, and it is indicated that the provided images are of sufficient<br>diagnostic quality. |

Table 2 Comparison of Technology Characteristics for Flat Panel Detector

| Model | Canon AS-401C<br>(K133693) | Mars1717XU-VSI<br>(K181413) | Remark |
|-----------------------|----------------------------------------|----------------------------------------------|---------|
| Application | General Radiography | General Radiography | Same |
| Scintillator material | Scintillator Cesium iodide<br>(CsI) | Scintillator Cesium iodide<br>(CsI) | Same |
| External Dimensions | 460 x 460 x 15.4 mm | 460 x 460 x 15.4 mm | Same |
| Installation Type | Wireless, Portable | Wireless, Portable | Same |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | Same |
| Pixel pitch | 125μm | 139µm | Note 13 |
| Active Image Area | $41.5cm×42.6cm$ | $42.7cm×42.7cm$ | Note 14 |
| Pixels | $3320×3408$ | $3072×3072$ | Note 15 |
| ADC Digitization | 16bit | 16bit | Same |
| DQE (Typical values) | 0.6 at 0 lp/mm | 0.65 at 0 lp/mm | Note 16 |
| MTF | 0.35 at 2 lp/mm | 0.35 at 2 lp/mm | Same |
| Communication | Wireless: IEEE<br>802.11n(2.4GHz/5GHz) | Wireless: IEEE<br>802.11a/b/g/n(2.4GHz/5GHz) | Note 17 |
| Cooling | Air cooling | Air cooling | Same |
| Weight | 3.8Kg | 3.8Kg | Same |

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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray. The logo is simple and modern.

| Justification | |
|---------------|---------------------------------------------------------------------------------------------------------------------------------|
| Note ID | Justification |
| Note 13 | 139µm is the mainstream Pixel pitch of DR detectors, which does not affect the safety and effectiveness in digital radiography. |
| Note 14 | Large effective radiographic size is convenience for positioning patient and exposure to big parts. |
| Note 15 | Pixels do not affect the safety and effectiveness in digital radiography. |
| Note 16 | Higher DQE does not affect the safety and effectiveness in digital radiography. |
| Note 17 | Support more communication protocol, does not affect the 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

Non-clinical testing including dosimetry and image performance tests were conducted for the uDR 592h, uDR 596i during the product development.

UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

## Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uDR 592h, uDR 596i in accordance with the following standards:

- A ES 60601-1:2005(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
- A 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.
- A 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.
- > 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.
- A 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
- A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

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Image /page/9/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 dark gray with a white vertical line running through the center. The logo is simple and modern.

### Performance Verification

- Clinical Evaluation for sample clinical images evaluation; A
- AEC Test Report. A

## 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
- A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- > Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

### Biocompatibility

- > ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

### Other Standards and Guidances

- ISO 14971: Medical Devices Application of risk management to medical A devices
- Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
- Code of Federal Regulations, Title 21, Subchapter J Radiological Health A
- A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)

### Software Verification and Validation

Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.

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. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.

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Image /page/10/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 words is a stylized "U" symbol. The logo is a dark gray color.

## Clinical Testing

No Clinical Study is included in this submission.

## Summary

The features described in this premarket submission are supported with the results of the testing mentioned above, the uDR 592h, uDR 596i was found to have a safety and effectiveness profile that is similar to the predicate device.

#### 9. Conclusions

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.