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.

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.

AI/ML Overview

The provided text does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria, especially for the newly added "cardiac (calcium scoring)" indication. The document is a 510(k) summary for a Computed Tomography X-ray System (uCT 530, uCT 550) seeking clearance for a modification that adds cardiac calcium scoring functionality.

Here's a breakdown of what is stated regarding performance and what is missing for the specific request:

What is provided:

Device Name: uCT 530, uCT 550
New Indication for Use: Cardiac (calcium scoring)
Justification for new indication: ECG gating tests and sample clinical images evaluation of calcium scoring scan showed the proposed device can obtain clinically acceptable calcium scoring images.
Performance Verification Tests conducted (general):
- Clinical Evaluation for sample clinical images evaluation
- AEC Test Report for AEC performance study
- MAC Performance Evaluation Report (Metal Artifact Correction)
- ECG R-Wave Detection Algorithm Performance Evaluation Report
Standards Conformance: A wide range of electrical safety, EMC, product, software, and biocompatibility standards were conformed to.
General assertion of equivalence: "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."
No Clinical Study: The document explicitly states "No Clinical Study is included in this submission."

What is missing from the document to answer your specific questions:

The document does not provide any specific quantitative acceptance criteria or detailed results of the studies for the new cardiac (calcium scoring) feature. It merely states that "ECG gating tests and sample clinical images evaluation of calcium scoring scan showed the proposed device can obtain clinically acceptable calcium scoring images." This is a general statement of positive outcome, not a detailed report of criteria or performance.

Therefore, for almost all your specific questions (1-7, and details for 8 and 9), the information is not present in the provided text.

Based on the provided text, I can only provide the following:

Acceptance Criteria and Study for uCT 530/550 (Cardiac Calcium Scoring)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated in text for calcium scoring)	Reported Device Performance (Summary from text for calcium scoring)
No specific quantitative criteria are provided in the document for the calcium scoring feature. For example, it does not specify a target accuracy for calcium score measurement, a minimum detectability of calcifications, or a maximum acceptable motion artifact level.	"the proposed device can obtain clinically acceptablecalcium scoring images."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document mentions "sample clinical images evaluation" but does not give a number of images or patients.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified. The phrase "clinical images evaluation" implies assessment by experts, but the method (e.g., consensus, independent reads) is not detailed.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No. The document explicitly states "No Clinical Study is included in this submission." The evaluation appears to be a review of image quality rather than a human-in-the-loop study with human readers.
Effect Size: Not applicable, as no such study was conducted or reported.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document implies the system's ability to produce "clinically acceptable calcium scoring images" based on "ECG gating tests and sample clinical images evaluation." This suggests an assessment of the system's output, which can be considered a form of standalone performance evaluation for the imaging capability.
The ECG R-Wave Detection Algorithm Performance Evaluation Report would be a standalone evaluation of a component algorithm. However, the details of its performance or acceptance criteria are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: The ground truth for "clinically acceptable" images would implicitly be based on expert subjective evaluation of the images. No objective ground truth (e.g., quantitative calcium scores from a reference standard, pathology confirmed calcifications, or patient outcomes) is mentioned.

8. The sample size for the training set:

The document does not describe the training set for any algorithms, as it focuses on the device's substantial equivalence to predicates and its modified features. The mention of "KARL iterative denoising reconstruction algorithm" and "MAC Metal artifact correction algorithm" implies underlying algorithms, but their training data specifics are not provided.

9. How the ground truth for the training set was established:

Not applicable, as details on training sets for any algorithms are not provided.

Summary

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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)

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 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.Model	HV Power	Rotation speed	Minimumslice thickness	Maximum slicesgenerated per rotation
uCT 530	50kW	Up to 0.5 sec per360° rotation	0.55mm	40
uCT 550	50kW	Up to 0.5 sec per360° 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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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 DeviceuCT 530, uCT 550	Primary Predicate Device: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 TomographyX-ray System uCT 530/550 is acomputed tomography x-raysystem intended to produce cross-sectional images of the body bycomputer reconstruction of x-raytransmission data taken at differentangles and planes and indicatedfor the whole body, includinghead, neck, cardiac(calcium scoring) and vascular.	The uCT Computed TomographyX-ray System uCT 530/550 is acomputed tomography x-raysystem intended to produce cross-sectional images of the body bycomputer reconstruction of x-raytransmission data taken atdifferent angles and planes andindicated for the whole body(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 scanAxial scanHelical scanContrast enhanced scanStationary perfusion scanGating scan	Scout scanAxial scanHelical scanContrast enhanced scanStationary perfusion scan	Note 2
DetectorMaterial	Solid-state GOS	Solid-state GOS	Same
Z-planecoverage	22mm	22mm	Same
Size of detectorelement in Z-plane	0.55mm	0.55mm	Same
Number ofelement per row	864	864	Same
Number ofdetector row	40	40	Same
Maximumslices generatedper rotation(multi-slicecapability)	40 for uCT 53080 for uCT 550	40 for uCT 53080 for uCT 550	Same
Minimum slicethickness	0.55mm	0.55mm	Same
Maximumsampling rate	Up to 4800 views per 360°	Up to 4800 views per 360°	Same
Tube anodestorage capacity	5.3MHU	5.3MHU	Same
Maximumcooling rate	815 kHU/min	815 kHU/min	Same
Focal spot size	0.5x1.0mm1.0x1.0mm	0.5x1.0mm1.0x1.0mm	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
Scannablerange	1700 mm	1700 mm	Same
Horizontalmotion range	2180 mm	2180 mm	Same
TableHorizontalSpeed	Up to 200mm/sec	Up to 200mm/sec	Same
Vertical motionrange	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
TableHorizontalPositionaccuracy	$\pm$ 0.25mm	$\pm$ 0.25mm	Same
TableMaximum tableload	205kg	205kg	Same
Image SpatialResolution	High mode:>20 lp/cm @ MTF 0%	High mode:>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 slicethickness, CTDIvol 28.9 mGy	3.0 $\pm$ 0.5 HU at 120 kV, 5 mm slicethickness, CTDIvol 28.9 mGy	Same
CT NumberDisplay Range	-1024 ~+8191 HU	-1024 ~+8191 HU	Same
Scan Field ofView	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
ReconstructionField of View	40mm-500mm40mm-600mm with extend FOV	40mm-500mm40mm-600mm with extend FOV	Same
Maximumscannablelength	1700mm	1700mm	Same
Image Matrix	Up to 1024 x 1024	Up to 1024 x 1024	Same
Reconstructedslice thickness	0.55mm,1.1mm,2.2mm,5.5mm,11mm (axial)0.55-10mm(helical)	0.55mm,1.1mm,2.2mm,5.5mm,11mm (axial)0.55-10mm(helical)	Same
Pitch	0.1~2.0	0.1~2.0	Same
Maximumcontinuousexposure time	Up to 100seconds	Up to 100seconds	Same
VSM	Operating voltage: 3.7V DCCommon-mode rejection [allowed10V(rms) line-frequency noise]:≤1mV (p-v RTI)Signal reduction of the injectedfrequency: <20% (0.67Hz ~40Hz)System noise: ≤30μV (p-v RTI)Frequency response: 80%~~110%Heart rate range: 30bpm~~200bpm	Not Applicable	Note 3
ApplicationFeatures
Iterative noise	KARL 3D	KARL 3D	Same
reduction	Adaptive Filter	Adaptive Filter	Same
Metal artifactreduction	MAC	MAC	Same
Safety
ElectricalSafety	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 weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10).	Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10).	Same
Clinical	Comparing with the predicate device (K181414), the difference of clinical image isdue to the addition of calcium scoring scan function. Sample clinical images ofcalcium 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 proposeddevice adds an indicated use for cardiac (calcium scoring). The proposed devicesupports a prospective ECG-gating axial scanning technique to reduce the artifact ofthe cardiac motion. ECG gating tests and sample clinical images evaluation ofcalcium scoring scan showed the proposed device can obtain clinically acceptablecalcium scoring images. The difference in indications for use does not affect thesafety and effectiveness.
Note 2	Provide additional gating scan mode compared with predicate device. For thedifference, through ECG gating tests and clinical image evaluation, proposed devicecan obtain clinically acceptable calcium scoring images. The difference of scanmodes does not affect the safety and effectiveness.
Note 3	Provide additional Vital Signal Module (VSM) that can transmit the patient's ECGto the system intended to trigger scan. The difference does not affect the safety andeffectiveness.

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 DeviceuCT 530, uCT 550	Secondary Predicate DeviceuCT 760, uCT 780 (K172135)	Remark
Hardware
VSM	Operating voltage: 3.7V DCCommon-mode rejection [allowed10V(rms) line-frequency noise]:<1mV (p-v RTI)	Operating voltage: 3.7V DCCommon-mode rejection [allowed10V(rms) line-frequency noise]:<1mV (p-v RTI)	Same
Scan Mode	Signal reduction of the injectedfrequency: ≤20% (0.67Hz ~40Hz)System noise: ≤30µV (p-v RTI)Frequency response: 80%~~110%Heart rate range: 30bpm~~200bpm	Signal reduction of the injectedfrequency: ≤20% (0.67Hz ~40Hz)System noise: ≤30µV (p-v RTI)Frequency response: 80%~~110%Heart rate range: 30bpm~~200bpm
Scout scan	The system supports acquiring andreconstructing image(s) for scoutscan including frontal scout,lateral scout, and dual scout.	The system supports acquiringand reconstructing image(s) forscout scan including frontal scout,lateral scout, and dual scout.	Same
Axial scan	The system supports acquiring andreconstructing image(s) for axialscan. During the x-ray exposure,the patient table remainsstationary; the table position maybe incremented between x-rayexposures to collect data over alonger z axis range.	The system supports acquiringand reconstructing image(s) foraxial scan. During the x-rayexposure, the patient tableremains stationary; the tableposition may be incrementedbetween x-ray exposures tocollect data over a longer z axisrange.	Same
Helical scan	The system supports acquiring andreconstructing image(s) for helicalscan. During the x-ray exposure,the patient table is continuouslymoving along the z axis.	The system supports acquiringand reconstructing image(s) forhelical scan. During the x-rayexposure, the patient table iscontinuously moving along the zaxis.	Same
Contrastenhanced scan	The system supports acquiring andreconstructing image(s) forcontrast enhanced scan withcontrast injection.	The system supports acquiringand reconstructing image(s) forcontrast enhanced scan withcontrast injection.	Same
Stationaryperfusion scan	The system supports acquiring andreconstructing image(s) at multipletime points over the same	The system supports acquiringand reconstructing image(s) atmultiple time points over the same	Same
	anatomic location(s) while thepatient table remains stationary.	anatomic location(s) while thepatient table remains stationary.
Gating Scan	The system supports controllingthe x-ray exposure based on theECG signal.Calcium scoring axial scan	The system supports controllingthe x-ray exposure based on theECG signal.Calcium scoring axial scanCalcium scoring helical scanCoronary CTA axial scanCoronary CTA helical scan	Note 4
Justification
Note ID	Justification
Note 4	The gating scan of proposed device can be covered by the predicate device, thereare no additional applications compared to the predicate device and the descriptiondifference 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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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.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.