uCT 530, uCT 550
Device Facts
| Record ID | K200016 |
|---|---|
| Device Name | uCT 530, uCT 550 |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. |
| Product Code | JAK · Radiology |
| Decision Date | Feb 25, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
Indications for Use
The uCT Computed Tomography X-ray System uCT 530/550 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
Device Story
The uCT 530/550 is a multi-slice CT scanner using a rotating tube-detector system and fan-beam geometry. It acquires X-ray transmission data at multiple angles, which a computer reconstructs into cross-sectional images. The system includes a gantry, X-ray source, detector array, patient table, and console. A Vital Signal Module (VSM) is integrated to capture ECG signals for prospective gating, enabling cardiac calcium scoring. The system employs Filtered Back-Projection (FBP) for reconstruction, with KARL 3D iterative denoising and MAC (Metal Artifact Correction) algorithms to enhance image quality. Operated by clinicians in a hospital or clinic setting, the system provides images for diagnostic review. The output assists physicians in identifying anatomical structures and pathologies, specifically supporting calcium scoring workflows. The device benefits patients by providing high-quality diagnostic images while managing radiation dose through standardized protocols.
Clinical Evidence
No clinical study was included in this submission. Substantial equivalence is supported by bench testing, including dosimetry, image performance tests, electrical safety (ES60601-1), EMC (IEC60601-1-2), and software verification/validation. Sample clinical images were provided to demonstrate the diagnostic quality of the new calcium scoring function.
Technological Characteristics
Multi-slice CT scanner; solid-state GOS detectors; 50kW generator; 700mm aperture; 0.5s rotation speed; 0.55mm minimum slice thickness. Features KARL 3D iterative denoising and MAC metal artifact correction. Includes VSM for ECG gating. Connectivity via DICOM. Software includes patient/data management and image reconstruction. Biocompatibility per ISO 10993-5/10.
Indications for Use
Indicated for whole-body CT imaging, including head, neck, vascular, and cardiac (calcium scoring) applications in patients requiring cross-sectional diagnostic imaging.
Regulatory Classification
Identification
A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Predicate Devices
Submission Summary (Full Text)
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Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 CHINA
February 25, 2020
### Re: K200016
Trade/Device Name: uCT 530, uCT 550 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: January 2, 2020 Received: January 3, 2020
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 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-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
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# Indications for Use
510(k) Number (if known)
K200016
Device Name
uCT 530, uCT 550
Indications for Use (Describe)
The uCT Computed Tomography X-ray System uCT530/550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
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/2 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 dark gray. The logo is simple and modern.
# 510 (k) SUMMARY
- 1. Date of Preparation February 15, 2020
#### 2. Sponsor Identification
# Shanghai United Imaging Healthcare Co.,Ltd.
No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin Gao Position: RA Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
#### 3. Identification of Proposed Device
Trade Name: uCT 530, uCT 550 Common Name: Computed Tomography X-ray System Model(s): uCT 530, uCT 550
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
#### 4. Identification of Predicate Device(s)
Primary Predicate Device:
510(k) Number: K181414 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 530, uCT 550
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
### Secondary Predicate Device:
510(k) Number: K172135 Device Name: uCT Computed Tomography X-Ray System Model(s): uCT 760, uCT 780
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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED 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.
Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology
#### 5. Device Description:
The uCT 530/uCT 550 is a multi-slice X-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system provides the filter back-projection (FBP) algorithm to reconstruct images in DICOM format, which can be used by post-processing applications.
The system consists of the Gantry, X-ray System, Data Management System, Patient Table, Console, Power Supply Cabinet, Image Processing Computer, and Software. The system software is a program used for patient management, data management, X-ray scan control, image reconstruction, and image archive.
A motorized patient table moves the patient through a circular opening in the Gantry. As the patient passes through the Gantry, a source of x rays rotates around the inside of the circular opening. Detectors on the exit side of the patient record the X rays exiting the section of the patient's body being irradiated as an X-ray "snapshot". Many different "snapshots" (angles) are collected during one complete rotation. The data are sent to a computer to reconstruct all of the individual "snapshots" into a cross-sectional image (slice) of the internal organs and tissues for each complete rotation of the source of x rays.
There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.
| Spec.<br>Model | HV Power | Rotation speed | Minimum<br>slice thickness | Maximum slices<br>generated per rotation |
|----------------|----------|------------------------------------|----------------------------|------------------------------------------|
| uCT 530 | 50kW | Up to 0.5 sec per<br>360° rotation | 0.55mm | 40 |
| uCT 550 | 50kW | Up to 0.5 sec per<br>360° rotation | 0.55mm | 80 |
This proposed device includes two models: uCT 530. uCT 550.The differences between the two models are as follows:
The uCT 530, uCT 550 have been previously cleared by FDA via K181414. The modifications performed on the uCT 530, uCT 550 (K181414) in this submission are due to the addition of the calcium scoring scan function. Meanwhile some component descriptions have been updated. The modifications are listed 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". To the right of the text is a stylized letter "U" that is dark gray. The logo is simple and modern.
- Indications for use: cardiac (calcium scoring) is stated in this submission. >
- > Hardware: Vital Signal Module (VSM) hardware is added to the system.
- > Software: workflow of Calcium scoring scan is added to the system.
- > Component Descriptions:
- Update the description of DMS frame and detector building block = (DBB).
- Update the description of the console PC' CPU.
- . Update the description of the gantry control PC' CPU.
- Update the description of the monitor's size.
#### Indications for Use 6.
The uCT Computed Tomography X-ray System uCT 530/550 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.
#### 7. Comparison of Technological Characteristics with the Predicate Devices
Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the Primary Predicate Device:
| ITEM | Proposed Device<br>uCT 530, uCT 550 | Primary Predicate Device:<br>uCT 530, uCT 550 (K181414) | Remark |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| Product Code | JAK | JAK | Same |
| Regulation No. | 21 CFR 892.1750 | 21 CFR 892.1750 | Same |
| Class | II | II | Same |
| Intended Use | The uCT Computed Tomography<br>X-ray System uCT 530/550 is a<br>computed tomography x-ray<br>system intended to produce cross-<br>sectional images of the body by<br>computer reconstruction of x-ray<br>transmission data taken at different<br>angles and planes and indicated<br>for the whole body, including<br>head, neck, cardiac<br>(calcium scoring) and vascular. | The uCT Computed Tomography<br>X-ray System uCT 530/550 is a<br>computed tomography x-ray<br>system intended to produce cross-<br>sectional images of the body by<br>computer reconstruction of x-ray<br>transmission data taken at<br>different angles and planes and<br>indicated for the whole body<br>(including head, neck, vascular). | Note 1 |
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Image /page/6/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" symbol, which is composed of two vertical lines and a horizontal line in the middle, creating a shape that resembles a "U" with a crossbar.
| Specifications | | | |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------|
| Scan Regime | Continuous Rotation | Continuous Rotation | Same |
| Scan Modes | Scout scan<br>Axial scan<br>Helical scan<br>Contrast enhanced scan<br>Stationary perfusion scan<br>Gating scan | Scout scan<br>Axial scan<br>Helical scan<br>Contrast enhanced scan<br>Stationary perfusion scan | Note 2 |
| Detector<br>Material | Solid-state GOS | Solid-state GOS | Same |
| Z-plane<br>coverage | 22mm | 22mm | Same |
| Size of detector<br>element in Z-<br>plane | 0.55mm | 0.55mm | Same |
| Number of<br>element per row | 864 | 864 | Same |
| Number of<br>detector row | 40 | 40 | Same |
| Maximum<br>slices generated<br>per rotation<br>(multi-slice<br>capability) | 40 for uCT 530<br>80 for uCT 550 | 40 for uCT 530<br>80 for uCT 550 | Same |
| Minimum slice<br>thickness | 0.55mm | 0.55mm | Same |
| Maximum<br>sampling rate | Up to 4800 views per 360° | Up to 4800 views per 360° | Same |
| Tube anode<br>storage capacity | 5.3MHU | 5.3MHU | Same |
| Maximum<br>cooling rate | 815 kHU/min | 815 kHU/min | Same |
| Focal spot size | 0.5x1.0mm<br>1.0x1.0mm | 0.5x1.0mm<br>1.0x1.0mm | Same |
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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" 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 blue and has a white line running vertically through the center.
| Power | 50kW | 50kW | Same |
|---------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|------|
| mA Range | 10-420mA | 10-420mA | Same |
| kV Settings | 70, 80, 100, 120, 140 | 70, 80, 100, 120, 140 | Same |
| Aperture | 700mm | 700mm | Same |
| Rotation speed | Up to 0.5 sec per 360° rotation | Up to 0.5 sec per 360° rotation | Same |
| Gantry Tilt | $\pm$ 30°with 0.5 increment | $\pm$ 30°with 0.5 increment | Same |
| Scannable<br>range | 1700 mm | 1700 mm | Same |
| Horizontal<br>motion range | 2180 mm | 2180 mm | Same |
| Table<br>Horizontal<br>Speed | Up to 200mm/sec | Up to 200mm/sec | Same |
| Vertical motion<br>range | 480 mm-950 mm from the floor | 480 mm-950 mm from the floor | Same |
| Vertical speed | Up to 40 mm/sec | Up to 40 mm/sec | Same |
| Table<br>Horizontal<br>Position<br>accuracy | $\pm$ 0.25mm | $\pm$ 0.25mm | Same |
| Table<br>Maximum table<br>load | 205kg | 205kg | Same |
| Image Spatial<br>Resolution | High mode:<br>>20 lp/cm @ MTF 0% | High mode:<br>>20 lp/cm @ MTF 0% | Same |
| | 16.5 $\pm$ 1.7 lp/cm @ MTF10% | 16.5 $\pm$ 1.7 lp/cm @ MTF10% | |
| | 11.5 $\pm$ 1.2 lp/cm @ MTF50% | 11.5 $\pm$ 1.2 lp/cm @ MTF50% | |
| Image Noise | 3.0 $\pm$ 0.5 HU at 120 kV, 5 mm slice<br>thickness, CTDIvol 28.9 mGy | 3.0 $\pm$ 0.5 HU at 120 kV, 5 mm slice<br>thickness, CTDIvol 28.9 mGy | Same |
| CT Number<br>Display Range | -1024 ~+8191 HU | -1024 ~+8191 HU | Same |
| Scan Field of<br>View | Up to 500 mm | Up to 500 mm | Same |
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Image /page/8/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" symbol, which is dark blue and has a white vertical line running through the center.
| | 600mm with extend FOV | 600mm with extend FOV | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------|
| Reconstruction<br>Field of View | 40mm-500mm<br>40mm-600mm with extend FOV | 40mm-500mm<br>40mm-600mm with extend FOV | Same |
| Maximum<br>scannable<br>length | 1700mm | 1700mm | Same |
| Image Matrix | Up to 1024 x 1024 | Up to 1024 x 1024 | Same |
| Reconstructed<br>slice thickness | 0.55mm,1.1mm,2.2mm,5.5mm,11<br>mm (axial)<br>0.55-10mm(helical) | 0.55mm,1.1mm,2.2mm,5.5mm,11<br>mm (axial)<br>0.55-10mm(helical) | Same |
| Pitch | 0.1~2.0 | 0.1~2.0 | Same |
| Maximum<br>continuous<br>exposure time | Up to 100seconds | Up to 100seconds | Same |
| VSM | Operating voltage: 3.7V DC<br>Common-mode rejection [allowed<br>10V(rms) line-frequency noise]:<br>≤1mV (p-v RTI)<br>Signal reduction of the injected<br>frequency: <20% (0.67Hz ~<br>40Hz)<br>System noise: ≤30μV (p-v RTI)<br>Frequency response: 80%~110%<br>Heart rate range: 30bpm~200bpm | Not Applicable | Note 3 |
| Application<br>Features | | | |
| Iterative noise | KARL 3D | KARL 3D | Same |
| reduction | Adaptive Filter | Adaptive Filter | Same |
| Metal artifact<br>reduction | MAC | MAC | Same |
| Safety | | | |
| Electrical<br>Safety | Comply with ES60601-1 | Comply with ES60601-1 | Same |
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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 words is a stylized "U" symbol, which is dark gray. The logo is simple and modern.
| 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). | Same |
| Clinical | Comparing with the predicate device (K181414), the difference of clinical image is<br>due to the addition of calcium scoring scan function. Sample clinical images of<br>calcium scoring scan provided are of diagnostic quality. | | |
| Justification | | | |
| Note ID | Justification | | |
| Note 1 | The difference in indications for use between the two devices is due to proposed<br>device adds an indicated use for cardiac (calcium scoring). The proposed device<br>supports a prospective ECG-gating axial scanning technique to reduce the artifact of<br>the cardiac motion. ECG gating tests and sample clinical images evaluation of<br>calcium scoring scan showed the proposed device can obtain clinically acceptable<br>calcium scoring images. The difference in indications for use does not affect the<br>safety and effectiveness. | | |
| Note 2 | Provide additional gating scan mode compared with predicate device. For the<br>difference, through ECG gating tests and clinical image evaluation, proposed device<br>can obtain clinically acceptable calcium scoring images. The difference of scan<br>modes does not affect the safety and effectiveness. | | |
| Note 3 | Provide additional Vital Signal Module (VSM) that can transmit the patient's ECG<br>to the system intended to trigger scan. The difference does not affect the safety and<br>effectiveness. | | |
Table 2 below provides a comparison of the technological characteristics of the proposed device in comparison to the Secondary Predicate Device.
Table 2 Comparison of Technological Characteristics
| ITEM | Proposed Device<br>uCT 530, uCT 550 | Secondary Predicate Device<br>uCT 760, uCT 780 (K172135) | Remark |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Hardware | | | |
| VSM | Operating voltage: 3.7V DC<br>Common-mode rejection [allowed<br>10V(rms) line-frequency noise]:<br><1mV (p-v RTI) | Operating voltage: 3.7V DC<br>Common-mode rejection [allowed<br>10V(rms) line-frequency noise]:<br><1mV (p-v RTI) | Same |
| Scan Mode | Signal reduction of the injected<br>frequency: ≤20% (0.67Hz ~<br>40Hz)<br>System noise: ≤30µV (p-v RTI)<br>Frequency response: 80%~110%<br>Heart rate range: 30bpm~200bpm | Signal reduction of the injected<br>frequency: ≤20% (0.67Hz ~<br>40Hz)<br>System noise: ≤30µV (p-v RTI)<br>Frequency response: 80%~110%<br>Heart rate range: 30bpm~200bpm | |
| Scout scan | The system supports acquiring and<br>reconstructing image(s) for scout<br>scan including frontal scout,<br>lateral scout, and dual scout. | The system supports acquiring<br>and reconstructing image(s) for<br>scout scan including frontal scout,<br>lateral scout, and dual scout. | Same |
| Axial scan | The system supports acquiring and<br>reconstructing image(s) for axial<br>scan. During the x-ray exposure,<br>the patient table remains<br>stationary; the table position may<br>be incremented between x-ray<br>exposures to collect data over a<br>longer z axis range. | The system supports acquiring<br>and reconstructing image(s) for<br>axial scan. During the x-ray<br>exposure, the patient table<br>remains stationary; the table<br>position may be incremented<br>between x-ray exposures to<br>collect data over a longer z axis<br>range. | Same |
| Helical scan | The system supports acquiring and<br>reconstructing image(s) for helical<br>scan. During the x-ray exposure,<br>the patient table is continuously<br>moving along the z axis. | The system supports acquiring<br>and reconstructing image(s) for<br>helical scan. During the x-ray<br>exposure, the patient table is<br>continuously moving along the z<br>axis. | Same |
| Contrast<br>enhanced scan | The system supports acquiring and<br>reconstructing image(s) for<br>contrast enhanced scan with<br>contrast injection. | The system supports acquiring<br>and reconstructing image(s) for<br>contrast enhanced scan with<br>contrast injection. | Same |
| Stationary<br>perfusion scan | The system supports acquiring and<br>reconstructing image(s) at multiple<br>time points over the same | The system supports acquiring<br>and reconstructing image(s) at<br>multiple time points over the same | Same |
| | anatomic location(s) while the<br>patient table remains stationary. | anatomic location(s) while the<br>patient table remains stationary. | |
| Gating Scan | The system supports controlling<br>the x-ray exposure based on the<br>ECG signal.<br>Calcium scoring axial scan | The system supports controlling<br>the x-ray exposure based on the<br>ECG signal.<br>Calcium scoring axial scan<br>Calcium scoring helical scan<br>Coronary CTA axial scan<br>Coronary CTA helical scan | Note 4 |
| Justification | | | |
| Note ID | Justification | | |
| Note 4 | The gating scan of proposed device can be covered by the predicate device, there<br>are no additional applications compared to the predicate device and the description<br>difference of two devices does not affect the safety and effectiveness. | | |
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Image /page/10/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 dark blue and has a white vertical line running through the center of it. The logo is simple and modern in design.
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Image /page/11/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, dark blue symbol that resembles a shield or a stylized letter "U" with a horizontal line through the middle.
#### Performance Data 8.
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 uCT 530/uCT 550 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 uCT 530/550 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
- > IEC 60601-2-44 Edition 3.2: 2016, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of X-ray Equipment For Computed Tomography
- > IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- > IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
# Product Particular Standards
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Image /page/12/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 text is a stylized "U" shape, which is also in a bold font. The color of the text and the "U" shape is a dark teal.
- NEMA XR 25-2010, Computed Tomography Dose Check >
- A NEMA XR 28-2013, Supplemental Requirements For User Information And System Function Related To Dose In CT
- A NEMA XR 29-2013, Standard Attributes on CT Equipment Related to Dose Optimization and Management
- 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 61223-3-5 First Edition 2004-08, Evaluation And Routine Testing In Medical Imaging Departments - Part 3-5: Acceptance Tests - Imaging Performance Of Computed Tomography X-ray Equipment
# Performance Verification
- Clinical Evaluation for sample clinical images evaluation A
- A AEC Test Report for AEC performance study
- A MAC Performance Evaluation Report
- > ECG R-Wave Detection Algorithm Performance Evaluation Report
### Software
- > NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM)
- > 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
# Biocompatibility
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical A 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
- 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)
- A Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
### 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.
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Image /page/13/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 text and the "U" shape is a dark gray.
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.
### 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 uCT 530/uCT 550 was found to have a safety and effectiveness profile that is similar to the predicate device.
#### Conclusions 9.
Based on the comparison and analysis above, the proposed device has same intended use, same performance, equivalence safety and effeteness as the predicate devices. The differences above between the proposed device and predicate devices do not affect the intended use, the 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 devices.
