uCT 760/780 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 indicated for the whole body (including head, neck, cardiac and vascular).

Device Description

The uCT 760/780 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, Vital Signal Module 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 crosssectional 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.

This proposed device includes two models: uCT 760, uCT 780.The differences between the two models are as follows:

Spec.Model	HV Power	Rotation speed	Minimumslice thickness	Maximum slicesgenerated per rotation
uCT 760	80kW	Up to 0.35 sec per360° rotation	0.625mm	128
uCT 780	100kW	Up to 0.3 sec per360° rotation	0.5mm	160

AI/ML Overview

The provided text describes a 510(k) summary for the uCT 760 and uCT 780 Computed Tomography X-ray systems, comparing them to a predicate device (Philips Plus CT scanner, models Brilliance 40 & 64). However, the document does not contain specific acceptance criteria and detailed study results for device performance.

Instead, it focuses on demonstrating substantial equivalence to the predicate device through comparisons of:

Technological Characteristics: Listed in Table 1, detailing various specifications like detector material, slice thickness, power, mA range, kV settings, and image resolution.
Application Features: Listed in Table 2, highlighting iterative noise reduction (KARL 3D vs. iDOSE) and metal artifact reduction (MAC vs. MAR).

The document states:

"No Clinical Study is included in this submission." (Page 13)
Performance data were provided through "Non-Clinical Testing including dosimetry and image performance tests" (Page 11). These tests were conducted during product development, but specific acceptance criteria and the results are not detailed in this provided summary.
It mentions "Clinical Evaluation for sample clinical images evaluation," "Artifact Evaluation Report for MAC performance study," and "Iterative Denoising Test Report for KARL performance study" as part of performance verification, but the actual data, methodologies, and acceptance criteria for these evaluations are not presented.

Therefore, based solely on the provided text, I cannot extract a table of acceptance criteria with reported device performance or details about the studies that prove the device meets these criteria as requested in your prompt. The document asserts that these tests were performed and the results supported the claim of substantial equivalence, but it does not provide the specifics.

However, I can extract the information that is present about the studies and evaluations:

1. A table of acceptance criteria and the reported device performance:

Not explicitly provided in the document. The document lists technological specifications for the proposed device and compares them to the predicate, with remarks indicating when the proposed device's performance is "better" (e.g., higher spatial resolution, lower image noise with specific CTDIvol) or "equivalent substantially." These are not framed as "acceptance criteria" but rather as comparative technical specifications that support substantial equivalence.

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

Not provided. The document mentions "sample clinical images evaluation" but does not specify the number of images or their origin.

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

Not provided. The document refers to "Clinical Evaluation for sample clinical images evaluation" but gives no details about the experts involved or how ground truth was established.

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

Not provided.

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:

No MRMC study was done. The device itself is a CT scanner, not an AI-assisted diagnostic tool for human readers in the context of comparative effectiveness for improved diagnostic accuracy. Its features, KARL iterative denoising and MAC metal artifact correction, are integrated reconstruction algorithms. The document states "No Clinical Study is included in this submission."

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

Yes, for certain aspects. The "Artifact Evaluation Report for MAC performance study" and "Iterative Denoising Test Report for KARL performance study" indicate standalone evaluations of these algorithms. However, explicit criteria and results are not provided. The main "device" (uCT 760/780) is a standalone system for image acquisition and reconstruction.

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

Not specified. For the "Clinical Evaluation for sample clinical images," the method for establishing ground truth is not detailed. For the technical performance tests (e.g., image noise, spatial resolution), generally, these are measured against established phantoms and physical standards rather than clinical ground truth alone.

8. The sample size for the training set:

Not applicable/Not provided. This device is a CT scanner with integrated reconstruction algorithms, not a machine learning model that would typically have a separate "training set" in the conventional sense of supervised learning. The algorithms (KARL, MAC) are developed through engineering and physics principles, likely refined using various datasets, but these are not specified as "training sets" in this context.

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

Not applicable/Not provided. (See point 8)

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

March 12, 2018

Re: K172135

Trade/Device Name: uCT 760, uCT 780 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: July 3, 2017 Received: July 14, 2017

Dear Shumei Wang:

This letter corrects our substantially equivalent letter of March 2, 2018.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert A. 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) K172135

Device Name uCT 760, uCT 780

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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510(k) Summary

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510 (k) SUMMARY

Date of Preparation 1. January 19, 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: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com

3. Identification of Proposed Device

Trade Name: uCT 760, uCT 780 Common Name: Computed Tomography X-ray System Model(s): uCT 760. uCT 780

Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

Identification of Predicate Device(s) 4.

Predicate Device

510(k) Number: K033326 Device Name: "Philips Plus" CT scanner Model(s): Brilliance 40, Brilliance 64

Regulatory Information Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: II Product Code: JAK Review Panel: Radiology

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5. Device Description:

There are two features for denoising and reduce metal artifact, which are KARL iterative denoising reconstruction algorithm and MAC Metal artifact correction algorithm.

This proposed device includes two models: uCT 760, uCT 780.The differences between the two models are as follows:

Spec.Model	HV Power	Rotation speed	Minimumslice thickness	Maximum slicesgenerated per rotation
uCT 760	80kW	Up to 0.35 sec per360° rotation	0.625mm	128
uCT 780	100kW	Up to 0.3 sec per360° rotation	0.5mm	160

6. Indications for Use

uCT 760/780 is a computed tomography X-ray system intended to produce crosssectional 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 and vascular).

Comparison of Technological Characteristics with the Predicate Devices 7.

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The uCT 760/780 Computed Tomography X-ray system has the same indications for use as the predicate device "Philips Plus" CT scanner. The fundamental scientific technology of the proposed device is same as the predicate device.

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

ITEM	Proposed DeviceuCT 760, uCT 780	Predicate DeviceBrilliance 40, Brilliance 64	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 ComputedTomography X-ray System is acomputed tomography x-raysystem intended to producecross-sectional images of thebody by computerreconstruction of x-raytransmission data taken atdifferent angles and planes andindicated for the whole body(including head, neck, cardiacand vascular).	The "Philips Plus" is a WholeBody Computed TomographyX-Ray System intended toproduce cross-sectionalimages of the body bycomputer reconstruction of x-ray transmission data taken atdifferent angles and planes.	Same
Specifications
Scan Regime	Continuous Rotation	Continuous Rotation	Same
Scan Modes	ScoutAxial ScanHelical Scan	SurviewAxial ScanHelical Scan	Same
DetectorMaterial	Solid-state GOS	Solid-state GOS	Same
Z-planecoverage	40mm	40mm	Same
Size of detectorelement in Z-plane	0.5mm	0.625mm	NoteNo.1
Number ofelement per row	936	672	NoteNo.2
Number ofdetector row	80	40 for Brilliance 4064 for Brilliance 64	NoteNo.3
Maximum slicesgenerated per	128 for uCT 760160 for uCT 780	40 for Brilliance 4064 for Brilliance 64	NoteNo.4
rotation (multi-slice capability)
Minimum slice thickness	0.625mm for uCT 7600.5mm for uCT 780	0.625mm	Same
Maximum sampling rate	Up to 4800 views per 360°	Up to 4640 views per 360°	Note No.5
Tube anode storage capacity	7.5MHU	8.0MHU	Note No.6
Maximum cooling rate	1386 kHU/min	1608kHU/min	Note No.7
Focal spot size	0.7x0.7mm1.0x1.0mm	0.5x1.0mm1.0x1.0mm	Note No.8
Power	80kW for uCT 760100 kW for uCT 780	60 kW	Note No.9
mA Range	6-667mA for uCT 7606-833mA for uCT 780	30-500mA for Brilliance 4020-500mA for Brilliance 64	Note No.10
kV Settings	70, 80, 100, 120, 140	80, 120, 140	Note No.11
Aperture	700mm	700mm	Same
Rotation speed	Up to 0.35 sec per 360° rotation for uCT 760Up to 0.3 sec per 360° rotation for uCT 780	Up to 0.42 sec per 360° rotation for Brilliance 40Up to 0.4 sec per 360° rotation for Brilliance 64	Note No.12
Temporal resolution	As low as 35ms	As low as 42ms	Note No.13
Gantry Tilt	± 30°with 0.5 increment	± 30°with 0.5 increment	Same
Scannable range	1700 mm	1750mm	Note No.14
Horizontal motion range	2180 mm	1900mm	Note No.15
Table Horizontal Speed	Up to 200mm/sec	Up to 143mm/sec	Note No.16
Vertical motion range	480 mm-950 mm from the floor	578-1028mm	Note No.17
Vertical speed	Up to 40 mm/sec	Up to 50mm/sec	Note No.18
Table Horizontal Position accuracy	±0.25mm	±0.25mm	Same
Table Maximum table load	205kg	204kg	Note No.19
Image Spatial Resolution	High mode:20 lp/cm @ MTF 0%	High mode:16.0lp/cm 0%	Note No.20

	16.5 lp/cm @ MTF10%11.5 lp/cm @ MTF50%	12.0 lp/cm @ MTF10%6.0 lp/cm @ MTF50%
Image Noise	3.0 HU at 120 kV, 5 mm slice thickness, CTDIvol 29.1mGy	4.0 HU at 120 kV, 5 mm slice thickness, CTDIvol 27.3mGy	NoteNo.21
CT NumberDisplay Range	-1024 ~+8191 HU	-1024 ~+3072 HU	NoteNo.22
Scan Field ofView	Up to 500 mm600mm with extend FOV	Up to 500 mm	Same
ReconstructionField of View	40mm-500mm40mm-600mm with extend FOV	50mm-500mm25mm-250mm (Ultra High mode)	NoteNo.23
Maximumscannable length	1700mm	1750mm	NoteNo.24
Image Matrix	Up to 1024 x 1024	Up to 1024 x 1024	Same
Reconstructedslice thickness	uCT 760:0.625mm,1.25mm,2.5mm,5mm,10mm (axial)0.625-10mm(helical)uCT 780:0.5mm,0.625mm,1.25mm,2.5mm,5mm,10mm (axial)0.5-10mm(helical)	Spiral mode:0.67 -7.5mmAxial mode:0.5-12mm	NoteNo.25
	Pitch	0.1~2.0	0.13~1.5	NoteNo.26
	Maximumcontinuousexposure time	Up to 100seconds	Up to 100seconds	Same
	Slip ring	6.25 Gbps transfer rate	Up to 5.3 Gbps transfer rate	NoteNo.27
	RAM	24GB for console PC32GB for Recon PC	2.0GB4.0GB (optional )	NoteNo.28
	Display	24inch, 1200 x 1920	19inch, 1024 x 1280	NoteNo.29
	Safety
Electrical Safety	Comply with ES60601-1	Comply with IEC60601-1	Same
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Same
Biocompatibility	Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10).	Comply with ISO10993-5,ISO10993-10	Same
	Clinical	Sample clinical image for both proposed and predicate devices areprovided in Section 15 Clinical Evaluation. Electronic file for each imageare provide in MISC Folder.

Table 1 Comparison of Technological Characteristics

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Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is formed by two vertical lines and a horizontal line connecting them at the top. The logo is simple and modern, and the use of bold fonts and geometric shapes gives it a strong and recognizable presence.

Note ID	Justification
Note 1	Provides the smaller minimum detector element size that induces higherz-plane spatial resolution for CT imaging, which does not affect safetyand effectiveness.
Note 2	Provides the larger detector element number per row that induces moredata sampling and higher spatial resolution per row for CT imaging,which does not affect safety and effectiveness.
Note 3	The move to 80 slices is the addition of physical detectors increasing thetotal number of slices to 80, which does not affect safety andeffectiveness.
Note 4	With a reconstruction process and reduction in (“windmill”) artifacts, 128slices or 160 slices can be achieved from the 80 detectors. Neither ofthese changes affects safety and effectiveness.
Note 5	Provides the larger maximum sampling rate based on the full view (360°)that induces more data sampling and higher spatial resolution for CTimaging, which does not affect safety and effectiveness.
Note 6	Tube anode storage capacity is a kind of measurement about themaximum throughput of CT scanner. When an independent scan isimplemented, the tube is heated and if the time interval between twoindependent scans is long enough, the heat can be dissipated timely butfor short scan time interval, the heat which has not been dissipated timelyshould be stored within tube device and thus for the continuous scans (forshort scan time intervals), higher storage capacity means that morecontinuous scan numbers can be supported. However, tube anode storagecapacity has no effect on each independent scan.
Note 7	Similarly with Note 7, maximum cooling rate is a kind of measurementabout the maximum throughput of CT scanner. For the continuous scans,higher maximum cooling rate means that the tube heat can be dissipatedfaster and thus shorter scan time interval and more continuous scannumbers can be supported. However, it has no effect on each independentscan.
Note 8	Focus spot size has effect on image spatial resolution and smaller size ishelpful for resolution improvement. However, the image spatial resolutionbetween the two kinds of devices is equivalent substantially.
Note 9	Provide the larger power output that induces higher ability of x-raypenetration when scanning the object with high BMI with lowerpossibility of photon starvation, and the safety has been evaluated by therelated testing and verification.
Note 10	Provide the larger mA output that induces higher ability of x-raypenetration when scanning the object with high BMI with lowerpossibility of photon starvation, and the safety has been evaluated by therelated testing and verification.
	of photon starvation, and the safety has been evaluated by the relatedtesting and verification.
Note 11	Provide small kV output such as 70kV that induces lower ability of x-raypenetration when scanning the object with low BMI with lower possibilityof photon starvation, and the safety has been evaluated by the relatedtesting and verification.Provide 100KV output that induces more feasible ability of x-ray penetration when scanning the object with various BMIs, and the safetyhas been evaluated by the related testing and verification.
Note 12	Provides the shorter minimum scan time that induces better temporalresolution in advanced clinical applications, including cardiac imaging,which does not affect safety and effectiveness.
Note 13	Provides the shorter temporal resolution that reduces motion artifacts ofcardiac imaging and increase the image quality, which does not affectsafety and effectiveness.
Note 14	Scannable range between the two kinds of devices is equivalentsubstantially because both of them can cover all kinds of the height rangeof current humans and they offer helical scanner mode to scan the wholebody from various human instead.
Note 15	Provide the larger horizontal motion range that induces larger scan range,which does not affect safety and effectiveness.
Note 16	Provide the larger table horizontal speed that induces shorter scan timewith the other given scan conditions such as scan range and parameters,which does not affect safety and effectiveness.
Note 17	Vertical motion range is decided by device gantry and couch designwhich does not affect safety and effectiveness.
Note 18	Vertical speed between the two kinds of devices is equivalentsubstantially and 10mm/sec difference does not affect safety andeffectiveness.
Note 19	The maximum table load between the two kinds of devices is equivalentsubstantially because both of them can cover all kinds of the load range ofcurrent humans.
Note 20	Providing the higher image spatial resolution is helpful to distinguish thesmaller structure, which does not affect safety and effectiveness.
Note 21	With 120 kV and 5mm slice thickness, the image noise for typical head is3HU on CTDIvol 29.1mGy, which is better than 4HU on CTDIvol27.3mGy. But the image noise level is equivalent substantiallyconsidering the proposed device has measured its noise based on thelarger CTDIvol than the Predicate Device.
Note 22	Provides the large HU range that induces more choice for various clinicalscan situation and show more information in clinical images, which doesnot affect safety and effectiveness.
Note 23	Reconstruction Field of View between the two kinds of devices isequivalent substantially and the difference from lower limits does notaffect safety and effectiveness.

Note 24	Maximum scannable length between the two kinds of devices is equivalent substantially because both of them can cover all kinds of the load range of current humans.
	Note 25	Provides the more slice thickness that induce more choice for various clinical scan situations and thinner slice thickness should bring higher spatial resolution in z-plane, which does not affect safety and effectiveness.
Note 26		Provides the large pitch range that induces more choice for various clinical scan situations, which does not affect safety and effectiveness.
		Note 27
Note 28
	Note 29

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The proposed device and the predicate device are the same in regard to most of application features.

Table 2 below provides a comparison of the application features of the proposed device in comparison to the predicate device.

ITEM	Proposed DeviceuCT 760, uCT 780	Predicate DeviceBrilliance 40, Brilliance 64	Remark
Application Features
Iterative noise reduction	KARL 3D	iDOSE	FunctionalEquivalent
	Adaptive Filter	Adaptive Filter	FunctionalEquivalent
Metal artifact reduction	MAC	MAR	FunctionalEquivalent

Table 2 Comparison of Application Features

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 760/780 during the product development.

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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 760/780 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 60601-2-44 Edition 3.0 2009, Medical Electrical Equipment - Part 2-44: Particular Requirements For The Basic Safety And Essential Performance Of Xray Equipment For Computed Tomography
A IEC 60601-1-2 Edition 3: 2007-03, 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 [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

Product Particular Standards

NEMA XR 25-2010, Computed Tomography Dose Check A
A NEMA XR 28-2013, Supplemental Requirements For User Information And System Function Related To Dose In CT
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
A 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 [Including: Technical Corrigendum 1 (2006)]

Performance Verification

A Clinical Evaluation for sample clinical images evaluation;
A Artifact Evaluation Report for MAC performance study;
A Iterative Denoising Test Report for KARL performance study;
AEC Test Report for AEC performance study.

Software

A NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM)
A IEC 62304: Medical Device Software - software life cycle process
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in

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Medical Devices

Biocompatibility

A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
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
Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
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.

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.

Summarv

The features described in this premarket submission are supported with the results of the testing mentioned above, the uCT 760/780 was found to have a safety and effectiveness profile that is similar to the predicate device.

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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.

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.